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Women with overactive bladder have access to an over-the-counter treatment for the first time, thanks to the Food and Drug Administration’s approval of Merck’s Oxytrol for Women Jan. 25.
This is a partial switch for the drug from prescription to over-the-counter, as men with overactive bladder still need a prescription for Oxytrol.
Although overactive bladder affects an estimated 33 million women, some studies suggest that many don’t seek treatment for it, and those who do seek treatment continue to have daily leakage (J. Urol. 2007;177:680-4).
"This effective, over-the-counter treatment offers women an option to independently manage their condition and achieve a newfound sense of control," Dr. Eman Elkadry of Harvard Medical School in Boston said in a statement issued by Merck. "The approval also provides recognition that this is a real medical disorder that can be addressed."
Each Oxytrol for Women patch is applied to the skin for 4 continuous days and nights, and delivers 3.9 mg of oxybutynin daily. Oxybutynin is an antispasmodic agent and is available in the United States under other prescription brand names, including Ditropan XL, Gelnique 3%, and Gelnique.
The safety and efficacy of the Oxytrol for Women patch were established in nine studies that included 5,000 participants, according to the FDA. "Overall, results from these studies showed that consumers can understand the information on the label, properly select whether the product is right for them, and use the drug appropriately," the agency noted.
The drug is not without side effects, although the ones reported in the studies were mild, including skin irritation at the site of the patch, dry mouth, and constipation, according to the FDA statement.
The announcement comes a week after the FDA approved Botox (onabotulinumtoxinA) for treatment of adults who don’t respond to a class of medications known as anticholinergics, which includes Oxytrol.
On Twitter @NaseemSMiller
Women with overactive bladder have access to an over-the-counter treatment for the first time, thanks to the Food and Drug Administration’s approval of Merck’s Oxytrol for Women Jan. 25.
This is a partial switch for the drug from prescription to over-the-counter, as men with overactive bladder still need a prescription for Oxytrol.
Although overactive bladder affects an estimated 33 million women, some studies suggest that many don’t seek treatment for it, and those who do seek treatment continue to have daily leakage (J. Urol. 2007;177:680-4).
"This effective, over-the-counter treatment offers women an option to independently manage their condition and achieve a newfound sense of control," Dr. Eman Elkadry of Harvard Medical School in Boston said in a statement issued by Merck. "The approval also provides recognition that this is a real medical disorder that can be addressed."
Each Oxytrol for Women patch is applied to the skin for 4 continuous days and nights, and delivers 3.9 mg of oxybutynin daily. Oxybutynin is an antispasmodic agent and is available in the United States under other prescription brand names, including Ditropan XL, Gelnique 3%, and Gelnique.
The safety and efficacy of the Oxytrol for Women patch were established in nine studies that included 5,000 participants, according to the FDA. "Overall, results from these studies showed that consumers can understand the information on the label, properly select whether the product is right for them, and use the drug appropriately," the agency noted.
The drug is not without side effects, although the ones reported in the studies were mild, including skin irritation at the site of the patch, dry mouth, and constipation, according to the FDA statement.
The announcement comes a week after the FDA approved Botox (onabotulinumtoxinA) for treatment of adults who don’t respond to a class of medications known as anticholinergics, which includes Oxytrol.
On Twitter @NaseemSMiller
Women with overactive bladder have access to an over-the-counter treatment for the first time, thanks to the Food and Drug Administration’s approval of Merck’s Oxytrol for Women Jan. 25.
This is a partial switch for the drug from prescription to over-the-counter, as men with overactive bladder still need a prescription for Oxytrol.
Although overactive bladder affects an estimated 33 million women, some studies suggest that many don’t seek treatment for it, and those who do seek treatment continue to have daily leakage (J. Urol. 2007;177:680-4).
"This effective, over-the-counter treatment offers women an option to independently manage their condition and achieve a newfound sense of control," Dr. Eman Elkadry of Harvard Medical School in Boston said in a statement issued by Merck. "The approval also provides recognition that this is a real medical disorder that can be addressed."
Each Oxytrol for Women patch is applied to the skin for 4 continuous days and nights, and delivers 3.9 mg of oxybutynin daily. Oxybutynin is an antispasmodic agent and is available in the United States under other prescription brand names, including Ditropan XL, Gelnique 3%, and Gelnique.
The safety and efficacy of the Oxytrol for Women patch were established in nine studies that included 5,000 participants, according to the FDA. "Overall, results from these studies showed that consumers can understand the information on the label, properly select whether the product is right for them, and use the drug appropriately," the agency noted.
The drug is not without side effects, although the ones reported in the studies were mild, including skin irritation at the site of the patch, dry mouth, and constipation, according to the FDA statement.
The announcement comes a week after the FDA approved Botox (onabotulinumtoxinA) for treatment of adults who don’t respond to a class of medications known as anticholinergics, which includes Oxytrol.
On Twitter @NaseemSMiller
