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Guanfacine has been approved by the Food and Drug Administration as an adjunct to stimulant medications for the treatment of attention-deficit/hyperactivity disorder in children and adolescents aged 6–17, the manufacturer announced in a statement.
The extended-release form of the drug, a selective alpha-2A adrenergic receptor agonist, previously had been approved as monotherapy for treating ADHD. The adjunctive therapy indication was based on a 9-week study of children and adolescents, according to the prescribing information for guanfacine, marketed as Intuniv by Shire PLC. The 9-week study included 455 patients with ADHD who had a suboptimal response to stimulant treatment.
Patients were randomized to receive a dose of guanfacine or placebo in the morning or evening or placebo in combination with the stimulant they had been receiving, with the dose of guanfacine starting at 1 mg titrated weekly over a 5-week period to a maximum of 4 mg/day, based on tolerability and clinical response.
At the end of 9 weeks, the mean reductions in total scores on the ADHD rating scale (ADHD-RS-IV) were significantly greater among those who received the combination than among those who continued on the psycho-stimulant alone.
The prescribing information states that it is indicated “as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, and social) for patients with this syndrome.”
Guanfacine has been approved by the Food and Drug Administration as an adjunct to stimulant medications for the treatment of attention-deficit/hyperactivity disorder in children and adolescents aged 6–17, the manufacturer announced in a statement.
The extended-release form of the drug, a selective alpha-2A adrenergic receptor agonist, previously had been approved as monotherapy for treating ADHD. The adjunctive therapy indication was based on a 9-week study of children and adolescents, according to the prescribing information for guanfacine, marketed as Intuniv by Shire PLC. The 9-week study included 455 patients with ADHD who had a suboptimal response to stimulant treatment.
Patients were randomized to receive a dose of guanfacine or placebo in the morning or evening or placebo in combination with the stimulant they had been receiving, with the dose of guanfacine starting at 1 mg titrated weekly over a 5-week period to a maximum of 4 mg/day, based on tolerability and clinical response.
At the end of 9 weeks, the mean reductions in total scores on the ADHD rating scale (ADHD-RS-IV) were significantly greater among those who received the combination than among those who continued on the psycho-stimulant alone.
The prescribing information states that it is indicated “as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, and social) for patients with this syndrome.”
Guanfacine has been approved by the Food and Drug Administration as an adjunct to stimulant medications for the treatment of attention-deficit/hyperactivity disorder in children and adolescents aged 6–17, the manufacturer announced in a statement.
The extended-release form of the drug, a selective alpha-2A adrenergic receptor agonist, previously had been approved as monotherapy for treating ADHD. The adjunctive therapy indication was based on a 9-week study of children and adolescents, according to the prescribing information for guanfacine, marketed as Intuniv by Shire PLC. The 9-week study included 455 patients with ADHD who had a suboptimal response to stimulant treatment.
Patients were randomized to receive a dose of guanfacine or placebo in the morning or evening or placebo in combination with the stimulant they had been receiving, with the dose of guanfacine starting at 1 mg titrated weekly over a 5-week period to a maximum of 4 mg/day, based on tolerability and clinical response.
At the end of 9 weeks, the mean reductions in total scores on the ADHD rating scale (ADHD-RS-IV) were significantly greater among those who received the combination than among those who continued on the psycho-stimulant alone.
The prescribing information states that it is indicated “as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, and social) for patients with this syndrome.”