Elizabeth Mechcatie

The Food and Drug Administration on Oct. 13 issued a warning about the “possible” risk of the rare atypical femur fractures associated with bisphosphonate treatment in osteoporosis patients, after reviewing the final report on this association released Sept. 14 by the American Society for Bone and Mineral Research.

The FDA has requested that a warning about the association be added to the labels of all bisphosphonates approved for osteoporosis prevention and treatment, and that a medication guide explaining the risk and the symptoms of these fractures be provided to patients with each bisphosphonate prescription, said Dr. Sandra Kweder during the briefing.

The agency also is requiring a change to the “indications and usage” section of the bisphosphonate labels, which will note that the optimal duration of treatment with bisphosphonates is not clear when they are used to treat and/or prevent osteoporosis.

In March 2010, the FDA announced that it was reviewing reports of femur fractures associated with bisphosphonate use, and the report issued by an American Society for Bone and Mineral Research (ASBMR) task force concluded that long-term bisphosphonate treatment may be related to an increased risk of these fractures, described as atypical fractures of the subtrochanteric region of the hip and femoral shaft (http://onlinelibrary.wiley.com/doi/10.1002/jbmr.253/pdf

The ASBMR report “helped us understand these fractures a little bit better and makes us confident that this is something that is potentially more closely related to these drugs, particularly [during] long-term use, than we previously had evidence for,” said Dr. Kweder, deputy director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research.

These fractures affect the femoral shaft, are less likely to be associated with trauma than are typical osteoporotic fractures, are sometimes bilateral, and generally affect younger patients, she said. Affected patients have described dull aching thigh or groin pain weeks to months before complete fracture is identified, she noted. The data indicate that they are more common in patients who have been on treatment for more than 5 years.

Similar to the recommendations in the ASBMR report, the FDA's recommendations to health care professionals include evaluating any patient who presents with new thigh or groin pain for a femur fracture, stopping treatment in patients with evidence of a femoral shaft fracture, and periodically reevaluating the need for continued treatment, particularly in patients treated for more than 5 years.

The products affected are those approved for osteoporosis indications, such as alendronate (Fosamax), alendronate and cholecalciferol (Fosamax Plus D), risedronate sodium (Actonel), risedronate sodium with calcium carbonate (Actonel with Calcium), ibandronate sodium (Boniva), risedronate sodium (Atelvia), pamidronate injection (Aredia), and zoledronic acid injection (Reclast), as well as generic formulations of those drugs.

The FDA advisory is available at www.fda.gov/Drugs/DrugSafety/ucm229009.htmwww.fda.gov/medwatch/

The Food and Drug Administration on Oct. 13 issued a warning about the “possible” risk of the rare atypical femur fractures associated with bisphosphonate treatment in osteoporosis patients, after reviewing the final report on this association released Sept. 14 by the American Society for Bone and Mineral Research.

The FDA has requested that a warning about the association be added to the labels of all bisphosphonates approved for osteoporosis prevention and treatment, and that a medication guide explaining the risk and the symptoms of these fractures be provided to patients with each bisphosphonate prescription, said Dr. Sandra Kweder during the briefing.

The agency also is requiring a change to the “indications and usage” section of the bisphosphonate labels, which will note that the optimal duration of treatment with bisphosphonates is not clear when they are used to treat and/or prevent osteoporosis.

In March 2010, the FDA announced that it was reviewing reports of femur fractures associated with bisphosphonate use, and the report issued by an American Society for Bone and Mineral Research (ASBMR) task force concluded that long-term bisphosphonate treatment may be related to an increased risk of these fractures, described as atypical fractures of the subtrochanteric region of the hip and femoral shaft (http://onlinelibrary.wiley.com/doi/10.1002/jbmr.253/pdf

The ASBMR report “helped us understand these fractures a little bit better and makes us confident that this is something that is potentially more closely related to these drugs, particularly [during] long-term use, than we previously had evidence for,” said Dr. Kweder, deputy director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research.

These fractures affect the femoral shaft, are less likely to be associated with trauma than are typical osteoporotic fractures, are sometimes bilateral, and generally affect younger patients, she said. Affected patients have described dull aching thigh or groin pain weeks to months before complete fracture is identified, she noted. The data indicate that they are more common in patients who have been on treatment for more than 5 years.

Similar to the recommendations in the ASBMR report, the FDA's recommendations to health care professionals include evaluating any patient who presents with new thigh or groin pain for a femur fracture, stopping treatment in patients with evidence of a femoral shaft fracture, and periodically reevaluating the need for continued treatment, particularly in patients treated for more than 5 years.

The products affected are those approved for osteoporosis indications, such as alendronate (Fosamax), alendronate and cholecalciferol (Fosamax Plus D), risedronate sodium (Actonel), risedronate sodium with calcium carbonate (Actonel with Calcium), ibandronate sodium (Boniva), risedronate sodium (Atelvia), pamidronate injection (Aredia), and zoledronic acid injection (Reclast), as well as generic formulations of those drugs.

The FDA advisory is available at www.fda.gov/Drugs/DrugSafety/ucm229009.htmwww.fda.gov/medwatch/

The Food and Drug Administration on Oct. 13 issued a warning about the “possible” risk of the rare atypical femur fractures associated with bisphosphonate treatment in osteoporosis patients, after reviewing the final report on this association released Sept. 14 by the American Society for Bone and Mineral Research.

The FDA has requested that a warning about the association be added to the labels of all bisphosphonates approved for osteoporosis prevention and treatment, and that a medication guide explaining the risk and the symptoms of these fractures be provided to patients with each bisphosphonate prescription, said Dr. Sandra Kweder during the briefing.

The agency also is requiring a change to the “indications and usage” section of the bisphosphonate labels, which will note that the optimal duration of treatment with bisphosphonates is not clear when they are used to treat and/or prevent osteoporosis.

In March 2010, the FDA announced that it was reviewing reports of femur fractures associated with bisphosphonate use, and the report issued by an American Society for Bone and Mineral Research (ASBMR) task force concluded that long-term bisphosphonate treatment may be related to an increased risk of these fractures, described as atypical fractures of the subtrochanteric region of the hip and femoral shaft (http://onlinelibrary.wiley.com/doi/10.1002/jbmr.253/pdf

The ASBMR report “helped us understand these fractures a little bit better and makes us confident that this is something that is potentially more closely related to these drugs, particularly [during] long-term use, than we previously had evidence for,” said Dr. Kweder, deputy director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research.

These fractures affect the femoral shaft, are less likely to be associated with trauma than are typical osteoporotic fractures, are sometimes bilateral, and generally affect younger patients, she said. Affected patients have described dull aching thigh or groin pain weeks to months before complete fracture is identified, she noted. The data indicate that they are more common in patients who have been on treatment for more than 5 years.

Similar to the recommendations in the ASBMR report, the FDA's recommendations to health care professionals include evaluating any patient who presents with new thigh or groin pain for a femur fracture, stopping treatment in patients with evidence of a femoral shaft fracture, and periodically reevaluating the need for continued treatment, particularly in patients treated for more than 5 years.

The products affected are those approved for osteoporosis indications, such as alendronate (Fosamax), alendronate and cholecalciferol (Fosamax Plus D), risedronate sodium (Actonel), risedronate sodium with calcium carbonate (Actonel with Calcium), ibandronate sodium (Boniva), risedronate sodium (Atelvia), pamidronate injection (Aredia), and zoledronic acid injection (Reclast), as well as generic formulations of those drugs.

The FDA advisory is available at www.fda.gov/Drugs/DrugSafety/ucm229009.htmwww.fda.gov/medwatch/

A drug that has been used to treat nerve gas and other types of pesticide and chemical poisoning in children off label for years is now approved for pediatric use, the Food and Drug Administration announced.

The drug, pralidoxime chloride, available as Protopam Chloride in the United States, was approved in 1964, as a treatment for poisoning caused by organophosphate pesticides and chemicals, such as nerve agents, in adults.

It is now available in an intramuscular formulation in addition to the previously available intravenous formulation. Protopam Chloride, manufactured by Baxter Healthcare Corp., works by acting as an antidote “by slowing the attachment of the chemical to nerve endings,” according to the FDA statement announcing the approval.

Because the drug is now approved for pediatric use, the label will include dosing information in children, which will provide health care professionals with information on “how to use this drug safely and effectively,” Dr. Russell Katz, director of the division of neurology products in the FDA's Center for Drug Evaluation and Research, said.

Using intravenous drugs in children, especially in emergency situations, can be difficult, so “having the new option of intramuscular injection might help health care professionals use this medicine quickly and accurately,” Dr. Dianne Murphy, director of the FDA's Office of Pediatric Therapeutics, pointed out in the statement.

Blurred vision, double vision, dizziness, headache, drowsiness, nausea, difficulty breathing, increased heart rate, and increased blood pressure are among the adverse reactions associated with the drug in adults and children, according to the FDA.

Symptoms associated with poisoning with organophosphate pesticides or chemicals can range from mild symptoms, such as a runny nose or vomiting, to serious symptoms that include difficulty breathing, weakness, and convulsions, according to the FDA statement.

A drug that has been used to treat nerve gas and other types of pesticide and chemical poisoning in children off label for years is now approved for pediatric use, the Food and Drug Administration announced.

The drug, pralidoxime chloride, available as Protopam Chloride in the United States, was approved in 1964, as a treatment for poisoning caused by organophosphate pesticides and chemicals, such as nerve agents, in adults.

It is now available in an intramuscular formulation in addition to the previously available intravenous formulation. Protopam Chloride, manufactured by Baxter Healthcare Corp., works by acting as an antidote “by slowing the attachment of the chemical to nerve endings,” according to the FDA statement announcing the approval.

Because the drug is now approved for pediatric use, the label will include dosing information in children, which will provide health care professionals with information on “how to use this drug safely and effectively,” Dr. Russell Katz, director of the division of neurology products in the FDA's Center for Drug Evaluation and Research, said.

Using intravenous drugs in children, especially in emergency situations, can be difficult, so “having the new option of intramuscular injection might help health care professionals use this medicine quickly and accurately,” Dr. Dianne Murphy, director of the FDA's Office of Pediatric Therapeutics, pointed out in the statement.

Blurred vision, double vision, dizziness, headache, drowsiness, nausea, difficulty breathing, increased heart rate, and increased blood pressure are among the adverse reactions associated with the drug in adults and children, according to the FDA.

Symptoms associated with poisoning with organophosphate pesticides or chemicals can range from mild symptoms, such as a runny nose or vomiting, to serious symptoms that include difficulty breathing, weakness, and convulsions, according to the FDA statement.

A drug that has been used to treat nerve gas and other types of pesticide and chemical poisoning in children off label for years is now approved for pediatric use, the Food and Drug Administration announced.

The drug, pralidoxime chloride, available as Protopam Chloride in the United States, was approved in 1964, as a treatment for poisoning caused by organophosphate pesticides and chemicals, such as nerve agents, in adults.

It is now available in an intramuscular formulation in addition to the previously available intravenous formulation. Protopam Chloride, manufactured by Baxter Healthcare Corp., works by acting as an antidote “by slowing the attachment of the chemical to nerve endings,” according to the FDA statement announcing the approval.

Because the drug is now approved for pediatric use, the label will include dosing information in children, which will provide health care professionals with information on “how to use this drug safely and effectively,” Dr. Russell Katz, director of the division of neurology products in the FDA's Center for Drug Evaluation and Research, said.

Using intravenous drugs in children, especially in emergency situations, can be difficult, so “having the new option of intramuscular injection might help health care professionals use this medicine quickly and accurately,” Dr. Dianne Murphy, director of the FDA's Office of Pediatric Therapeutics, pointed out in the statement.

Blurred vision, double vision, dizziness, headache, drowsiness, nausea, difficulty breathing, increased heart rate, and increased blood pressure are among the adverse reactions associated with the drug in adults and children, according to the FDA.

Symptoms associated with poisoning with organophosphate pesticides or chemicals can range from mild symptoms, such as a runny nose or vomiting, to serious symptoms that include difficulty breathing, weakness, and convulsions, according to the FDA statement.

BETHESDA, MD. – Advisors to the Food and Drug Administration voted 20-2 that the risk-benefit profile of sodium oxybate did not support approval of the sedative-hypnotic drug as a treatment for fibromyalgia, citing concerns that included the lack of long-term data and the potential for illicit use of the drug.

At the meeting, panelists generally agreed that the data from clinical trials showed that sodium oxybate, which is approved for treating cataplexy and daytime sleepiness associated with narcolepsy, was effective in treating fibromyalgia.

Panelists said the effect was modest, and that treatment may benefit only a subset of patients. They also said that it was unclear whether the results could be generalized to the typical fibromyalgia population and that more studies were needed, including those directly comparing sodium oxybate to other treatments for the disorder.

Sodium oxybate is the sodium salt of gamma hydroxybutyrate (GHB), an endogenous neurotransmitter synthesized from gamma aminobutyric acid, and is also known as the “date rape” drug. Sodium oxybate in an oral solution was approved in 2002 for narcolepsy and has been marketed as Xyrem by Jazz Pharmaceuticals, with a risk evaluation and mitigation (REMS) program that tightly controls availability of the drug and includes restricted distribution of the agent through one centralized pharmacy and other measures.

A main concern voiced by the panelists and FDA reviewers was if the drug were approved to treat fibromyalgia, its use would increase substantially—and its availability as a street drug could increase markedly, despite the controlled distribution.

The panelists were strongly against the company's proposal to use a different commercial name (Rekinla), concentration, and dose. They also opposed a different REMS for the fibromyalgia indication, with distribution through 15 specialized pharmacies, which they said was confusing and would increase the likelihood of medication errors.

The company proposed that patients would take two doses, one before going to sleep and the second in the middle of the night, which was also cited as a disadvantage for patients.

In two phase 3 randomized, double-blind, controlled 14-week studies, two different doses of sodium oxybate were compared to placebo in about 1,000 fibromyalgia patients aged 18 and older, who discontinued opiates, benzodiazepines, muscle relaxants, and other medications or devices before enrollment. A significantly greater proportion of those treated with sodium oxybate (36%-46%) met the primary end point, at least a 30% reduction in pain from baseline to the end of treatment, compared with those on placebo (20%-27%). Adverse events were similar to those observed in Xyrem trials.

Xyrem is also approved in the European Union and Canada for the treatment of symptoms associated with narcolepsy. The company anticipates that the drug would be used to treat up to 120,000 people with fibromyalgia in the United States.

The other drugs approved by the FDA for treating fibromyalgia are milnacipran (Savella), pregabalin (Lyrica), and duloxetine (Cymbalta).

The FDA usually follows the recommendations of its advisory panels. Panelists have been cleared of potential conflicts related to the topic of the meeting, although in some cases, a waiver is granted to a panelist.

BETHESDA, MD. – Advisors to the Food and Drug Administration voted 20-2 that the risk-benefit profile of sodium oxybate did not support approval of the sedative-hypnotic drug as a treatment for fibromyalgia, citing concerns that included the lack of long-term data and the potential for illicit use of the drug.

At the meeting, panelists generally agreed that the data from clinical trials showed that sodium oxybate, which is approved for treating cataplexy and daytime sleepiness associated with narcolepsy, was effective in treating fibromyalgia.

Panelists said the effect was modest, and that treatment may benefit only a subset of patients. They also said that it was unclear whether the results could be generalized to the typical fibromyalgia population and that more studies were needed, including those directly comparing sodium oxybate to other treatments for the disorder.

Sodium oxybate is the sodium salt of gamma hydroxybutyrate (GHB), an endogenous neurotransmitter synthesized from gamma aminobutyric acid, and is also known as the “date rape” drug. Sodium oxybate in an oral solution was approved in 2002 for narcolepsy and has been marketed as Xyrem by Jazz Pharmaceuticals, with a risk evaluation and mitigation (REMS) program that tightly controls availability of the drug and includes restricted distribution of the agent through one centralized pharmacy and other measures.

A main concern voiced by the panelists and FDA reviewers was if the drug were approved to treat fibromyalgia, its use would increase substantially—and its availability as a street drug could increase markedly, despite the controlled distribution.

The panelists were strongly against the company's proposal to use a different commercial name (Rekinla), concentration, and dose. They also opposed a different REMS for the fibromyalgia indication, with distribution through 15 specialized pharmacies, which they said was confusing and would increase the likelihood of medication errors.

The company proposed that patients would take two doses, one before going to sleep and the second in the middle of the night, which was also cited as a disadvantage for patients.

In two phase 3 randomized, double-blind, controlled 14-week studies, two different doses of sodium oxybate were compared to placebo in about 1,000 fibromyalgia patients aged 18 and older, who discontinued opiates, benzodiazepines, muscle relaxants, and other medications or devices before enrollment. A significantly greater proportion of those treated with sodium oxybate (36%-46%) met the primary end point, at least a 30% reduction in pain from baseline to the end of treatment, compared with those on placebo (20%-27%). Adverse events were similar to those observed in Xyrem trials.

Xyrem is also approved in the European Union and Canada for the treatment of symptoms associated with narcolepsy. The company anticipates that the drug would be used to treat up to 120,000 people with fibromyalgia in the United States.

The other drugs approved by the FDA for treating fibromyalgia are milnacipran (Savella), pregabalin (Lyrica), and duloxetine (Cymbalta).

The FDA usually follows the recommendations of its advisory panels. Panelists have been cleared of potential conflicts related to the topic of the meeting, although in some cases, a waiver is granted to a panelist.

BETHESDA, MD. – Advisors to the Food and Drug Administration voted 20-2 that the risk-benefit profile of sodium oxybate did not support approval of the sedative-hypnotic drug as a treatment for fibromyalgia, citing concerns that included the lack of long-term data and the potential for illicit use of the drug.

At the meeting, panelists generally agreed that the data from clinical trials showed that sodium oxybate, which is approved for treating cataplexy and daytime sleepiness associated with narcolepsy, was effective in treating fibromyalgia.

Panelists said the effect was modest, and that treatment may benefit only a subset of patients. They also said that it was unclear whether the results could be generalized to the typical fibromyalgia population and that more studies were needed, including those directly comparing sodium oxybate to other treatments for the disorder.

Sodium oxybate is the sodium salt of gamma hydroxybutyrate (GHB), an endogenous neurotransmitter synthesized from gamma aminobutyric acid, and is also known as the “date rape” drug. Sodium oxybate in an oral solution was approved in 2002 for narcolepsy and has been marketed as Xyrem by Jazz Pharmaceuticals, with a risk evaluation and mitigation (REMS) program that tightly controls availability of the drug and includes restricted distribution of the agent through one centralized pharmacy and other measures.

A main concern voiced by the panelists and FDA reviewers was if the drug were approved to treat fibromyalgia, its use would increase substantially—and its availability as a street drug could increase markedly, despite the controlled distribution.

The panelists were strongly against the company's proposal to use a different commercial name (Rekinla), concentration, and dose. They also opposed a different REMS for the fibromyalgia indication, with distribution through 15 specialized pharmacies, which they said was confusing and would increase the likelihood of medication errors.

The company proposed that patients would take two doses, one before going to sleep and the second in the middle of the night, which was also cited as a disadvantage for patients.

In two phase 3 randomized, double-blind, controlled 14-week studies, two different doses of sodium oxybate were compared to placebo in about 1,000 fibromyalgia patients aged 18 and older, who discontinued opiates, benzodiazepines, muscle relaxants, and other medications or devices before enrollment. A significantly greater proportion of those treated with sodium oxybate (36%-46%) met the primary end point, at least a 30% reduction in pain from baseline to the end of treatment, compared with those on placebo (20%-27%). Adverse events were similar to those observed in Xyrem trials.

Xyrem is also approved in the European Union and Canada for the treatment of symptoms associated with narcolepsy. The company anticipates that the drug would be used to treat up to 120,000 people with fibromyalgia in the United States.

The other drugs approved by the FDA for treating fibromyalgia are milnacipran (Savella), pregabalin (Lyrica), and duloxetine (Cymbalta).

The FDA usually follows the recommendations of its advisory panels. Panelists have been cleared of potential conflicts related to the topic of the meeting, although in some cases, a waiver is granted to a panelist.

The injectable extended-release formulation of naltrexone, marketed as Vivitrol, has been approved as a treatment for preventing relapses in people who have undergone opioid detoxification, the Food and Drug Administration has announced.

Vivitrol, approved in 2006 for the treatment of alcohol dependence, is administered in an intramuscular injection once a month, in patients who have no opioids remaining in their system. If opioids are present, patients may experience withdrawal symptoms, according to the FDA statement. Naltrexone is an opioid antagonist.

Approval was based on the results of a 6-month study of 250 patients who were completing or had recently completed detoxification and were no longer physically dependent on opioids. Between the 5th week and the end of the study, 36% of those treated with Vivitrol (one 380-mg injection once a month) had not used opioids at all, compared with 23% of those on placebo, a significant difference. All patients received psychosocial support during the study.

Side effects associated with Vivitrol treatment include nausea, fatigue, headache, dizziness, vomiting, reduced appetite, painful joints, and muscle cramps, the FDA statement said. Serious side effects include injection site reactions, allergic reactions, hepatotoxicity, and depression, as well as suicide and suicidal thoughts and behavior.

Customized needles provided in the Vivitrol package must be used to inject the medication as an intramuscular gluteal injection, according to the FDA and Alkermes Inc., the manufacturer of Vivitrol.

In the FDA statement, Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, described the approval as “a significant advancement in addiction treatment.”

The FDA has asked the company to conduct postmarketing pharmacokinetic and efficacy studies of Vivitrol in patients aged 12–16 years.

Serious adverse reactions associated with Vivitrol should be reported to the FDA's MedWatch program at 800-332-1088 or www.fda.gov/medwatch/

The injectable extended-release formulation of naltrexone, marketed as Vivitrol, has been approved as a treatment for preventing relapses in people who have undergone opioid detoxification, the Food and Drug Administration has announced.

Vivitrol, approved in 2006 for the treatment of alcohol dependence, is administered in an intramuscular injection once a month, in patients who have no opioids remaining in their system. If opioids are present, patients may experience withdrawal symptoms, according to the FDA statement. Naltrexone is an opioid antagonist.

Approval was based on the results of a 6-month study of 250 patients who were completing or had recently completed detoxification and were no longer physically dependent on opioids. Between the 5th week and the end of the study, 36% of those treated with Vivitrol (one 380-mg injection once a month) had not used opioids at all, compared with 23% of those on placebo, a significant difference. All patients received psychosocial support during the study.

Side effects associated with Vivitrol treatment include nausea, fatigue, headache, dizziness, vomiting, reduced appetite, painful joints, and muscle cramps, the FDA statement said. Serious side effects include injection site reactions, allergic reactions, hepatotoxicity, and depression, as well as suicide and suicidal thoughts and behavior.

Customized needles provided in the Vivitrol package must be used to inject the medication as an intramuscular gluteal injection, according to the FDA and Alkermes Inc., the manufacturer of Vivitrol.

In the FDA statement, Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, described the approval as “a significant advancement in addiction treatment.”

The FDA has asked the company to conduct postmarketing pharmacokinetic and efficacy studies of Vivitrol in patients aged 12–16 years.

Serious adverse reactions associated with Vivitrol should be reported to the FDA's MedWatch program at 800-332-1088 or www.fda.gov/medwatch/

The injectable extended-release formulation of naltrexone, marketed as Vivitrol, has been approved as a treatment for preventing relapses in people who have undergone opioid detoxification, the Food and Drug Administration has announced.

Vivitrol, approved in 2006 for the treatment of alcohol dependence, is administered in an intramuscular injection once a month, in patients who have no opioids remaining in their system. If opioids are present, patients may experience withdrawal symptoms, according to the FDA statement. Naltrexone is an opioid antagonist.

Approval was based on the results of a 6-month study of 250 patients who were completing or had recently completed detoxification and were no longer physically dependent on opioids. Between the 5th week and the end of the study, 36% of those treated with Vivitrol (one 380-mg injection once a month) had not used opioids at all, compared with 23% of those on placebo, a significant difference. All patients received psychosocial support during the study.

Side effects associated with Vivitrol treatment include nausea, fatigue, headache, dizziness, vomiting, reduced appetite, painful joints, and muscle cramps, the FDA statement said. Serious side effects include injection site reactions, allergic reactions, hepatotoxicity, and depression, as well as suicide and suicidal thoughts and behavior.

Customized needles provided in the Vivitrol package must be used to inject the medication as an intramuscular gluteal injection, according to the FDA and Alkermes Inc., the manufacturer of Vivitrol.

In the FDA statement, Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, described the approval as “a significant advancement in addiction treatment.”

The FDA has asked the company to conduct postmarketing pharmacokinetic and efficacy studies of Vivitrol in patients aged 12–16 years.

Serious adverse reactions associated with Vivitrol should be reported to the FDA's MedWatch program at 800-332-1088 or www.fda.gov/medwatch/

Another atypical antipsychotic, lurasidone, has been approved for treating adults with schizophrenia. The approval was based on the results of four short-term studies, the Food and Drug Administration announced.

In the four 6-week placebo-controlled studies of almost 1,300 adults with schizophrenia, those treated with lurasidone had a greater response to treatment than did those on placebo, as measured by different scales used to evaluate response to treatment in patients with schizophrenia, according to the drug's prescribing information.

Lurasidone, which comes in a tablet formulation, will be marketed by Sunovion Pharmaceuticals Inc. as Latuda. It will be available in February 2011, according to the company, previously called Sepracor Inc.

An initial dose of 40 mg is recommended; the maximum recommended dose is 80 mg once a day.

In the studies, the most common adverse events associated with treatment were drowsiness, akathisia, nausea, movement abnormalities, and agitation, according to the FDA's statement announcing the approval. In the statement, Dr. Thomas Laughren, director of the division of psychiatry products in the FDA's Center for Drug Evaluation and Research, referred to the importance of having multiple treatment options available for treating schizophrenia, because “some patients do not respond well to certain types of drug therapy.”

In an interview, psychiatrist Rakesh Karmacharya said that although lurasidone is “not drastically different from a mechanistic or a scientific viewpoint” from other atypical antipsychotics, it is “certainly helpful” to have another drug available to treat schizophrenia, since some patients respond to one drug and not to another, and patients might experience side effects with one drug but not another.

More experience and longer term use should determine whether lurasidone is associated with less weight gain and sedation than some of the other atypicals, noted Dr. Karmacharya, the medical director of the schizophrenia and bipolar disorder research clinic, McLean Hospital, Belmont, Mass.

He referred to preclinical data indicating that lurasidone binds weakly to receptors implicated in antipsychotic-induced weight gain, sedation, and cognitive effects, which might lead to a more favorable side-effect profile with long-term use, when compared to some of the other atypicals.

The preclinical data found that lurasidone binds weakly to histamine H1 receptors, which have been implicated in weight gain and sedation, to the 5HT2C receptor, which has also been implicated in weight gain, and to muscarinic receptors, which might be involved in some of the cognitive effects associated with antipsychotics, said Dr. Karmacharya, also of Harvard University.

He added that in the short-term clinical studies, lurasidone was not associated with weight gain but said that more experience with the drug is needed.

Dr. Karmacharya had no conflicts relevant to the approval.

Another atypical antipsychotic, lurasidone, has been approved for treating adults with schizophrenia. The approval was based on the results of four short-term studies, the Food and Drug Administration announced.

In the four 6-week placebo-controlled studies of almost 1,300 adults with schizophrenia, those treated with lurasidone had a greater response to treatment than did those on placebo, as measured by different scales used to evaluate response to treatment in patients with schizophrenia, according to the drug's prescribing information.

Lurasidone, which comes in a tablet formulation, will be marketed by Sunovion Pharmaceuticals Inc. as Latuda. It will be available in February 2011, according to the company, previously called Sepracor Inc.

An initial dose of 40 mg is recommended; the maximum recommended dose is 80 mg once a day.

In the studies, the most common adverse events associated with treatment were drowsiness, akathisia, nausea, movement abnormalities, and agitation, according to the FDA's statement announcing the approval. In the statement, Dr. Thomas Laughren, director of the division of psychiatry products in the FDA's Center for Drug Evaluation and Research, referred to the importance of having multiple treatment options available for treating schizophrenia, because “some patients do not respond well to certain types of drug therapy.”

In an interview, psychiatrist Rakesh Karmacharya said that although lurasidone is “not drastically different from a mechanistic or a scientific viewpoint” from other atypical antipsychotics, it is “certainly helpful” to have another drug available to treat schizophrenia, since some patients respond to one drug and not to another, and patients might experience side effects with one drug but not another.

More experience and longer term use should determine whether lurasidone is associated with less weight gain and sedation than some of the other atypicals, noted Dr. Karmacharya, the medical director of the schizophrenia and bipolar disorder research clinic, McLean Hospital, Belmont, Mass.

He referred to preclinical data indicating that lurasidone binds weakly to receptors implicated in antipsychotic-induced weight gain, sedation, and cognitive effects, which might lead to a more favorable side-effect profile with long-term use, when compared to some of the other atypicals.

The preclinical data found that lurasidone binds weakly to histamine H1 receptors, which have been implicated in weight gain and sedation, to the 5HT2C receptor, which has also been implicated in weight gain, and to muscarinic receptors, which might be involved in some of the cognitive effects associated with antipsychotics, said Dr. Karmacharya, also of Harvard University.

He added that in the short-term clinical studies, lurasidone was not associated with weight gain but said that more experience with the drug is needed.

Dr. Karmacharya had no conflicts relevant to the approval.

Another atypical antipsychotic, lurasidone, has been approved for treating adults with schizophrenia. The approval was based on the results of four short-term studies, the Food and Drug Administration announced.

In the four 6-week placebo-controlled studies of almost 1,300 adults with schizophrenia, those treated with lurasidone had a greater response to treatment than did those on placebo, as measured by different scales used to evaluate response to treatment in patients with schizophrenia, according to the drug's prescribing information.

Lurasidone, which comes in a tablet formulation, will be marketed by Sunovion Pharmaceuticals Inc. as Latuda. It will be available in February 2011, according to the company, previously called Sepracor Inc.

An initial dose of 40 mg is recommended; the maximum recommended dose is 80 mg once a day.

In the studies, the most common adverse events associated with treatment were drowsiness, akathisia, nausea, movement abnormalities, and agitation, according to the FDA's statement announcing the approval. In the statement, Dr. Thomas Laughren, director of the division of psychiatry products in the FDA's Center for Drug Evaluation and Research, referred to the importance of having multiple treatment options available for treating schizophrenia, because “some patients do not respond well to certain types of drug therapy.”

In an interview, psychiatrist Rakesh Karmacharya said that although lurasidone is “not drastically different from a mechanistic or a scientific viewpoint” from other atypical antipsychotics, it is “certainly helpful” to have another drug available to treat schizophrenia, since some patients respond to one drug and not to another, and patients might experience side effects with one drug but not another.

More experience and longer term use should determine whether lurasidone is associated with less weight gain and sedation than some of the other atypicals, noted Dr. Karmacharya, the medical director of the schizophrenia and bipolar disorder research clinic, McLean Hospital, Belmont, Mass.

He referred to preclinical data indicating that lurasidone binds weakly to receptors implicated in antipsychotic-induced weight gain, sedation, and cognitive effects, which might lead to a more favorable side-effect profile with long-term use, when compared to some of the other atypicals.

The preclinical data found that lurasidone binds weakly to histamine H1 receptors, which have been implicated in weight gain and sedation, to the 5HT2C receptor, which has also been implicated in weight gain, and to muscarinic receptors, which might be involved in some of the cognitive effects associated with antipsychotics, said Dr. Karmacharya, also of Harvard University.

He added that in the short-term clinical studies, lurasidone was not associated with weight gain but said that more experience with the drug is needed.

Dr. Karmacharya had no conflicts relevant to the approval.

Ceftaroline, an intravenous cephalosporin antibiotic, has been approved for treating community- acquired bacterial pneumonia and for acute bacterial skin and skin structure infections, including methicillin-resistant Staphylococcus aureus, the Food and Drug Administration announced on Oct. 29.

The approved prescribing information of ceftaroline states that it is indicated for:

– the treatment of community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: Streptococcus pneumoniae (including cases with concurrent bacteremia), Staphylococcus aureus (methicillin-susceptible isolates only), Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli.

– the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following gram-positive and gram-negative micro-organisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, and Klebsiella oxytoca.

Approval was based on four phase III studies of patients aged 18 years and older. In the two studies of 1,231 patients with CABP, the effectiveness of treatment with ceftaroline was found to be comparable to that of ceftriaxone (Rocephin), the comparator drug, in the studies, according to the FDA statement announcing the approval.

In the two studies of almost 1,400 patients with ABSSSIs, treatment with ceftaroline was found to be comparable to that of the combination of vancomycin (Vancocin) and aztreonam (Azactam).

Diarrhea, nausea, and rash are among the most commonly reported side effects associated with ceftaroline, according to the FDA.

At a meeting in September, an FDA advisory panel backed the approval of the drug for these two indications.

Ceftaroline will be marketed as Teflaro by Forest Laboratories Inc. The company plans to have the drug available in January 2011.

Ceftaroline, an intravenous cephalosporin antibiotic, has been approved for treating community- acquired bacterial pneumonia and for acute bacterial skin and skin structure infections, including methicillin-resistant Staphylococcus aureus, the Food and Drug Administration announced on Oct. 29.

The approved prescribing information of ceftaroline states that it is indicated for:

– the treatment of community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: Streptococcus pneumoniae (including cases with concurrent bacteremia), Staphylococcus aureus (methicillin-susceptible isolates only), Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli.

– the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following gram-positive and gram-negative micro-organisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, and Klebsiella oxytoca.

Approval was based on four phase III studies of patients aged 18 years and older. In the two studies of 1,231 patients with CABP, the effectiveness of treatment with ceftaroline was found to be comparable to that of ceftriaxone (Rocephin), the comparator drug, in the studies, according to the FDA statement announcing the approval.

In the two studies of almost 1,400 patients with ABSSSIs, treatment with ceftaroline was found to be comparable to that of the combination of vancomycin (Vancocin) and aztreonam (Azactam).

Diarrhea, nausea, and rash are among the most commonly reported side effects associated with ceftaroline, according to the FDA.

At a meeting in September, an FDA advisory panel backed the approval of the drug for these two indications.

Ceftaroline will be marketed as Teflaro by Forest Laboratories Inc. The company plans to have the drug available in January 2011.

Ceftaroline, an intravenous cephalosporin antibiotic, has been approved for treating community- acquired bacterial pneumonia and for acute bacterial skin and skin structure infections, including methicillin-resistant Staphylococcus aureus, the Food and Drug Administration announced on Oct. 29.

The approved prescribing information of ceftaroline states that it is indicated for:

– the treatment of community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: Streptococcus pneumoniae (including cases with concurrent bacteremia), Staphylococcus aureus (methicillin-susceptible isolates only), Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli.

– the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following gram-positive and gram-negative micro-organisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, and Klebsiella oxytoca.

Approval was based on four phase III studies of patients aged 18 years and older. In the two studies of 1,231 patients with CABP, the effectiveness of treatment with ceftaroline was found to be comparable to that of ceftriaxone (Rocephin), the comparator drug, in the studies, according to the FDA statement announcing the approval.

In the two studies of almost 1,400 patients with ABSSSIs, treatment with ceftaroline was found to be comparable to that of the combination of vancomycin (Vancocin) and aztreonam (Azactam).

Diarrhea, nausea, and rash are among the most commonly reported side effects associated with ceftaroline, according to the FDA.

At a meeting in September, an FDA advisory panel backed the approval of the drug for these two indications.

Ceftaroline will be marketed as Teflaro by Forest Laboratories Inc. The company plans to have the drug available in January 2011.

Lurasidone, an atypical antipsychotic, has been approved for treating adults with schizophrenia, the Food and Drug Administration announced Oct. 28.

The approval of lurasidone was based on the results of four 6-week placebo-controlled studies of almost 1,300 adults with schizophrenia, which found that those treated with lurasidone had a greater response to treatment with lurasidone than did those on placebo, as measured by different scales used to evaluate response to treatment in patients with schizophrenia, according to the drug’s prescribing information.

Lurasidone, which comes in a tablet formulation, will be marketed by Sunovion Pharmaceuticals Inc. as Latuda. It will be available in February 2011, according to the company, which was previously called Sepracor Inc.

A recommended initial dose of 40 mg is recommended; the maximum recommended dose is 80 mg once a day.

In the studies, the most common adverse events associated with treatment were drowsiness, akathisia, nausea, movement abnormalities, and agitation, according to the FDA’s statement announcing the approval. Like other atypical antipsychotics, the label of lurasidone has a boxed warning about the increased risk of death when these drugs are used off label to treat elderly patients with dementia-related psychosis. None of the atypical antipsychotics is approved for that indication.

In the FDA statement, Dr. Thomas Laughren, director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research, referred to the importance of having multiple treatment options available for treating schizophrenia, because "some patients do not respond well to certain types of drug therapy."

Lurasidone, an atypical antipsychotic, has been approved for treating adults with schizophrenia, the Food and Drug Administration announced Oct. 28.

The approval of lurasidone was based on the results of four 6-week placebo-controlled studies of almost 1,300 adults with schizophrenia, which found that those treated with lurasidone had a greater response to treatment with lurasidone than did those on placebo, as measured by different scales used to evaluate response to treatment in patients with schizophrenia, according to the drug’s prescribing information.

Lurasidone, which comes in a tablet formulation, will be marketed by Sunovion Pharmaceuticals Inc. as Latuda. It will be available in February 2011, according to the company, which was previously called Sepracor Inc.

A recommended initial dose of 40 mg is recommended; the maximum recommended dose is 80 mg once a day.

In the studies, the most common adverse events associated with treatment were drowsiness, akathisia, nausea, movement abnormalities, and agitation, according to the FDA’s statement announcing the approval. Like other atypical antipsychotics, the label of lurasidone has a boxed warning about the increased risk of death when these drugs are used off label to treat elderly patients with dementia-related psychosis. None of the atypical antipsychotics is approved for that indication.

In the FDA statement, Dr. Thomas Laughren, director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research, referred to the importance of having multiple treatment options available for treating schizophrenia, because "some patients do not respond well to certain types of drug therapy."

Lurasidone, an atypical antipsychotic, has been approved for treating adults with schizophrenia, the Food and Drug Administration announced Oct. 28.

The approval of lurasidone was based on the results of four 6-week placebo-controlled studies of almost 1,300 adults with schizophrenia, which found that those treated with lurasidone had a greater response to treatment with lurasidone than did those on placebo, as measured by different scales used to evaluate response to treatment in patients with schizophrenia, according to the drug’s prescribing information.

Lurasidone, which comes in a tablet formulation, will be marketed by Sunovion Pharmaceuticals Inc. as Latuda. It will be available in February 2011, according to the company, which was previously called Sepracor Inc.

A recommended initial dose of 40 mg is recommended; the maximum recommended dose is 80 mg once a day.

In the studies, the most common adverse events associated with treatment were drowsiness, akathisia, nausea, movement abnormalities, and agitation, according to the FDA’s statement announcing the approval. Like other atypical antipsychotics, the label of lurasidone has a boxed warning about the increased risk of death when these drugs are used off label to treat elderly patients with dementia-related psychosis. None of the atypical antipsychotics is approved for that indication.

In the FDA statement, Dr. Thomas Laughren, director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research, referred to the importance of having multiple treatment options available for treating schizophrenia, because "some patients do not respond well to certain types of drug therapy."

The approval of dasatinib, an oral kinase inhibitor, has been expanded to include the initial treatment of Philadelphia chromosome–positive chronic-phase chronic myeloid leukemia (Ph+ CP-CML), the Food and Drug Administration announced on Oct. 28.

The approval was based on an open-label, randomized study of the safety and efficacy of dasatinib in patients with CP-CML. The study evaluated gene-based measures of the responses of malignant cells to treatment, according to a statement issued by the FDA.

Myelosuppression, fluid retention, diarrhea, headache, musculoskeletal pain, and rash are among the most common adverse effects associated with treatment, according to the FDA.

Dasatinib, marketed as Sprycel by Bristol-Myers Squibb Co., was first approved in 2006 to treat adults with CP-CML who had resistant disease or who were intolerant to previous treatment, including imatinib (Gleevec). That was an accelerated approval based on early data; the full approval was in 2009, based on 24-month follow-up data from studies confirming that the drug was safe and effective for this indication, according to the FDA.

It is the third drug approved for Ph+ CP-CML through the accelerated approval process, which allows the FDA to approve a drug for a serious disease that has an unmet medical need based on an end point "thought to reasonably predict clinical benefit," according to the statement. A condition of accelerated approval is that the drug’s manufacturer must confirm the benefit of the drug with long-term efficacy and safety data.

In the FDA statement, Dr. Richard Pazdur, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, said that the drugs that have received accelerated approval "have dramatically changed the lives of patients with CML." Results from additional CML studies "continue to demonstrate the importance of studying cancer drugs in the earlier stages of a disease," he added.

In some cases, the long-term data show no benefits, and the approval is rescinded. Other FDA-approved treatments for different types of CML include imatinib, approved in 2001, and nilotinib (Tasigna), approved in 2007.

The approval of dasatinib, an oral kinase inhibitor, has been expanded to include the initial treatment of Philadelphia chromosome–positive chronic-phase chronic myeloid leukemia (Ph+ CP-CML), the Food and Drug Administration announced on Oct. 28.

The approval was based on an open-label, randomized study of the safety and efficacy of dasatinib in patients with CP-CML. The study evaluated gene-based measures of the responses of malignant cells to treatment, according to a statement issued by the FDA.

Myelosuppression, fluid retention, diarrhea, headache, musculoskeletal pain, and rash are among the most common adverse effects associated with treatment, according to the FDA.

Dasatinib, marketed as Sprycel by Bristol-Myers Squibb Co., was first approved in 2006 to treat adults with CP-CML who had resistant disease or who were intolerant to previous treatment, including imatinib (Gleevec). That was an accelerated approval based on early data; the full approval was in 2009, based on 24-month follow-up data from studies confirming that the drug was safe and effective for this indication, according to the FDA.

It is the third drug approved for Ph+ CP-CML through the accelerated approval process, which allows the FDA to approve a drug for a serious disease that has an unmet medical need based on an end point "thought to reasonably predict clinical benefit," according to the statement. A condition of accelerated approval is that the drug’s manufacturer must confirm the benefit of the drug with long-term efficacy and safety data.

In the FDA statement, Dr. Richard Pazdur, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, said that the drugs that have received accelerated approval "have dramatically changed the lives of patients with CML." Results from additional CML studies "continue to demonstrate the importance of studying cancer drugs in the earlier stages of a disease," he added.

In some cases, the long-term data show no benefits, and the approval is rescinded. Other FDA-approved treatments for different types of CML include imatinib, approved in 2001, and nilotinib (Tasigna), approved in 2007.

The approval of dasatinib, an oral kinase inhibitor, has been expanded to include the initial treatment of Philadelphia chromosome–positive chronic-phase chronic myeloid leukemia (Ph+ CP-CML), the Food and Drug Administration announced on Oct. 28.

The approval was based on an open-label, randomized study of the safety and efficacy of dasatinib in patients with CP-CML. The study evaluated gene-based measures of the responses of malignant cells to treatment, according to a statement issued by the FDA.

Myelosuppression, fluid retention, diarrhea, headache, musculoskeletal pain, and rash are among the most common adverse effects associated with treatment, according to the FDA.

Dasatinib, marketed as Sprycel by Bristol-Myers Squibb Co., was first approved in 2006 to treat adults with CP-CML who had resistant disease or who were intolerant to previous treatment, including imatinib (Gleevec). That was an accelerated approval based on early data; the full approval was in 2009, based on 24-month follow-up data from studies confirming that the drug was safe and effective for this indication, according to the FDA.

It is the third drug approved for Ph+ CP-CML through the accelerated approval process, which allows the FDA to approve a drug for a serious disease that has an unmet medical need based on an end point "thought to reasonably predict clinical benefit," according to the statement. A condition of accelerated approval is that the drug’s manufacturer must confirm the benefit of the drug with long-term efficacy and safety data.

In the FDA statement, Dr. Richard Pazdur, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, said that the drugs that have received accelerated approval "have dramatically changed the lives of patients with CML." Results from additional CML studies "continue to demonstrate the importance of studying cancer drugs in the earlier stages of a disease," he added.

In some cases, the long-term data show no benefits, and the approval is rescinded. Other FDA-approved treatments for different types of CML include imatinib, approved in 2001, and nilotinib (Tasigna), approved in 2007.

The nucleoside analogue entecavir has been approved by the Food and Drug Administration for treating chronic hepatitis B in adults with decompensated liver disease, the manufacturer announced.

Approval was based on data from an ongoing study that randomized patients with chronic hepatitis B and decompensated liver disease to treatment with entecavir, at a dose of 1 mg once daily, or the nucleotide analogue adefovir (10 mg once daily), according to a statement issued by Bristol-Myers Squibb (BMS).

Entecavir, first approved by the FDA in 2005 for treating chronic hepatitis B in adults with compensated liver disease, is marketed as Baraclude by BMS.

The open label, controlled, phase 3b study enrolled HBeAg-positive or HBeAg-negative patients with chronic hepatitis B and evidence of hepatic decompensation, who had never been treated for hepatitis B virus (HBV) or had been treated predominantly with lamivudine or interferon-alpha; 100 patients were randomized to receive entecavir, 91 to receive adefovir.

At 48 weeks, 57% of the patients in the entecavir arm had an undetectable HBV DNA viral load (less than 300 copies/mL), compared with 20% of those on adefovir, according to BMS. Among the patients with abnormal alanine aminotransferase levels at baseline, more of those treated with entecavir achieved normal levels at 48 weeks, compared with those treated with adefovir (63% vs. 46%, respectively). Loss of hepatitis B surface antigen was seen in 5% of those on entecavir, compared with none of those treated with adefovir.

However, slightly more patients on adefovir (67%) showed improvement, or no worsening, in their Child-Turcotte-Pugh scores, compared with 61% of those on entecavir.

The most common adverse events reported in patients treated with entecavir through 48 weeks were peripheral edema (16%), ascites (15%), pyrexia (14%), hepatic encephalopathy (10%), and upper respiratory infection (10%), according to the company statement.

The study is the ETV-048 trial.

Approved in 2002, adefovir (Hepsera) is indicated for the treatment of chronic hepatitis B in patients 12 years of age and older with evidence of active viral replication and either persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

The nucleoside analogue entecavir has been approved by the Food and Drug Administration for treating chronic hepatitis B in adults with decompensated liver disease, the manufacturer announced.

Approval was based on data from an ongoing study that randomized patients with chronic hepatitis B and decompensated liver disease to treatment with entecavir, at a dose of 1 mg once daily, or the nucleotide analogue adefovir (10 mg once daily), according to a statement issued by Bristol-Myers Squibb (BMS).

Entecavir, first approved by the FDA in 2005 for treating chronic hepatitis B in adults with compensated liver disease, is marketed as Baraclude by BMS.

The open label, controlled, phase 3b study enrolled HBeAg-positive or HBeAg-negative patients with chronic hepatitis B and evidence of hepatic decompensation, who had never been treated for hepatitis B virus (HBV) or had been treated predominantly with lamivudine or interferon-alpha; 100 patients were randomized to receive entecavir, 91 to receive adefovir.

At 48 weeks, 57% of the patients in the entecavir arm had an undetectable HBV DNA viral load (less than 300 copies/mL), compared with 20% of those on adefovir, according to BMS. Among the patients with abnormal alanine aminotransferase levels at baseline, more of those treated with entecavir achieved normal levels at 48 weeks, compared with those treated with adefovir (63% vs. 46%, respectively). Loss of hepatitis B surface antigen was seen in 5% of those on entecavir, compared with none of those treated with adefovir.

However, slightly more patients on adefovir (67%) showed improvement, or no worsening, in their Child-Turcotte-Pugh scores, compared with 61% of those on entecavir.

The most common adverse events reported in patients treated with entecavir through 48 weeks were peripheral edema (16%), ascites (15%), pyrexia (14%), hepatic encephalopathy (10%), and upper respiratory infection (10%), according to the company statement.

The study is the ETV-048 trial.

Approved in 2002, adefovir (Hepsera) is indicated for the treatment of chronic hepatitis B in patients 12 years of age and older with evidence of active viral replication and either persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

The nucleoside analogue entecavir has been approved by the Food and Drug Administration for treating chronic hepatitis B in adults with decompensated liver disease, the manufacturer announced.

Approval was based on data from an ongoing study that randomized patients with chronic hepatitis B and decompensated liver disease to treatment with entecavir, at a dose of 1 mg once daily, or the nucleotide analogue adefovir (10 mg once daily), according to a statement issued by Bristol-Myers Squibb (BMS).

Entecavir, first approved by the FDA in 2005 for treating chronic hepatitis B in adults with compensated liver disease, is marketed as Baraclude by BMS.

The open label, controlled, phase 3b study enrolled HBeAg-positive or HBeAg-negative patients with chronic hepatitis B and evidence of hepatic decompensation, who had never been treated for hepatitis B virus (HBV) or had been treated predominantly with lamivudine or interferon-alpha; 100 patients were randomized to receive entecavir, 91 to receive adefovir.

At 48 weeks, 57% of the patients in the entecavir arm had an undetectable HBV DNA viral load (less than 300 copies/mL), compared with 20% of those on adefovir, according to BMS. Among the patients with abnormal alanine aminotransferase levels at baseline, more of those treated with entecavir achieved normal levels at 48 weeks, compared with those treated with adefovir (63% vs. 46%, respectively). Loss of hepatitis B surface antigen was seen in 5% of those on entecavir, compared with none of those treated with adefovir.

However, slightly more patients on adefovir (67%) showed improvement, or no worsening, in their Child-Turcotte-Pugh scores, compared with 61% of those on entecavir.

The most common adverse events reported in patients treated with entecavir through 48 weeks were peripheral edema (16%), ascites (15%), pyrexia (14%), hepatic encephalopathy (10%), and upper respiratory infection (10%), according to the company statement.

The study is the ETV-048 trial.

Approved in 2002, adefovir (Hepsera) is indicated for the treatment of chronic hepatitis B in patients 12 years of age and older with evidence of active viral replication and either persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

The nucleoside analogue entecavir has been approved by the Food and Drug Administration for treating chronic hepatitis B in adults with decompensated liver disease, the manufacturer announced.

Approval was based on data from an ongoing study that randomized patients with chronic hepatitis B and decompensated liver disease to treatment with entecavir, at a dose of 1 mg once daily, or the nucleotide analogue adefovir (10 mg once daily), according to a statement issued by Bristol-Myers Squibb (BMS).

Entecavir, first approved by the FDA in 2005 for treating chronic hepatitis B in adults with compensated liver disease, is marketed as Baraclude by BMS.

The open label, controlled, phase 3b study enrolled HBeAg-positive or HBeAg-negative patients with chronic hepatitis B and evidence of hepatic decompensation, who had never been treated for hepatitis B virus (HBV) or had been treated predominantly with lamivudine or interferon-alpha; 100 patients were randomized to receive entecavir, 91 to receive adefovir.

At 48 weeks, 57% of the patients in the entecavir arm had an undetectable HBV DNA viral load (less than 300 copies/mL), compared with 20% of those on adefovir, according to BMS. Among the patients with abnormal alanine aminotransferase levels at baseline, more of those treated with entecavir achieved normal levels at 48 weeks, compared with those treated with adefovir (63% vs. 46%, respectively). Loss of hepatitis B surface antigen was seen in 5% of those on entecavir, compared with none of those treated with adefovir.

However, slightly more patients on adefovir (67%) showed improvement, or no worsening, in their Child-Turcotte-Pugh scores, compared with 61% of those on entecavir.

The most common adverse events reported in patients treated with entecavir through 48 weeks were peripheral edema (16%), ascites (15%), pyrexia (14%), hepatic encephalopathy (10%), and upper respiratory infection (10%), according to the company statement.

The study is the ETV-048 trial.

Approved in 2002, adefovir (Hepsera) is indicated for the treatment of chronic hepatitis B in patients 12 years of age and older with evidence of active viral replication and either persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

The nucleoside analogue entecavir has been approved by the Food and Drug Administration for treating chronic hepatitis B in adults with decompensated liver disease, the manufacturer announced.

Approval was based on data from an ongoing study that randomized patients with chronic hepatitis B and decompensated liver disease to treatment with entecavir, at a dose of 1 mg once daily, or the nucleotide analogue adefovir (10 mg once daily), according to a statement issued by Bristol-Myers Squibb (BMS).

Entecavir, first approved by the FDA in 2005 for treating chronic hepatitis B in adults with compensated liver disease, is marketed as Baraclude by BMS.

The open label, controlled, phase 3b study enrolled HBeAg-positive or HBeAg-negative patients with chronic hepatitis B and evidence of hepatic decompensation, who had never been treated for hepatitis B virus (HBV) or had been treated predominantly with lamivudine or interferon-alpha; 100 patients were randomized to receive entecavir, 91 to receive adefovir.

At 48 weeks, 57% of the patients in the entecavir arm had an undetectable HBV DNA viral load (less than 300 copies/mL), compared with 20% of those on adefovir, according to BMS. Among the patients with abnormal alanine aminotransferase levels at baseline, more of those treated with entecavir achieved normal levels at 48 weeks, compared with those treated with adefovir (63% vs. 46%, respectively). Loss of hepatitis B surface antigen was seen in 5% of those on entecavir, compared with none of those treated with adefovir.

However, slightly more patients on adefovir (67%) showed improvement, or no worsening, in their Child-Turcotte-Pugh scores, compared with 61% of those on entecavir.

The most common adverse events reported in patients treated with entecavir through 48 weeks were peripheral edema (16%), ascites (15%), pyrexia (14%), hepatic encephalopathy (10%), and upper respiratory infection (10%), according to the company statement.

The study is the ETV-048 trial.

Approved in 2002, adefovir (Hepsera) is indicated for the treatment of chronic hepatitis B in patients 12 years of age and older with evidence of active viral replication and either persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

The nucleoside analogue entecavir has been approved by the Food and Drug Administration for treating chronic hepatitis B in adults with decompensated liver disease, the manufacturer announced.

Approval was based on data from an ongoing study that randomized patients with chronic hepatitis B and decompensated liver disease to treatment with entecavir, at a dose of 1 mg once daily, or the nucleotide analogue adefovir (10 mg once daily), according to a statement issued by Bristol-Myers Squibb (BMS).

Entecavir, first approved by the FDA in 2005 for treating chronic hepatitis B in adults with compensated liver disease, is marketed as Baraclude by BMS.

The open label, controlled, phase 3b study enrolled HBeAg-positive or HBeAg-negative patients with chronic hepatitis B and evidence of hepatic decompensation, who had never been treated for hepatitis B virus (HBV) or had been treated predominantly with lamivudine or interferon-alpha; 100 patients were randomized to receive entecavir, 91 to receive adefovir.

At 48 weeks, 57% of the patients in the entecavir arm had an undetectable HBV DNA viral load (less than 300 copies/mL), compared with 20% of those on adefovir, according to BMS. Among the patients with abnormal alanine aminotransferase levels at baseline, more of those treated with entecavir achieved normal levels at 48 weeks, compared with those treated with adefovir (63% vs. 46%, respectively). Loss of hepatitis B surface antigen was seen in 5% of those on entecavir, compared with none of those treated with adefovir.

However, slightly more patients on adefovir (67%) showed improvement, or no worsening, in their Child-Turcotte-Pugh scores, compared with 61% of those on entecavir.

The most common adverse events reported in patients treated with entecavir through 48 weeks were peripheral edema (16%), ascites (15%), pyrexia (14%), hepatic encephalopathy (10%), and upper respiratory infection (10%), according to the company statement.

The study is the ETV-048 trial.

Approved in 2002, adefovir (Hepsera) is indicated for the treatment of chronic hepatitis B in patients 12 years of age and older with evidence of active viral replication and either persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.