FDA approves Intuniv for ADHD
Wednesday, March 9, 2011
Shire, a global biopharmaceutical company, said the FDA approved the use of once-daily
Intuniv (guanfacine) extended-release tablets as adjunctive therapy to stimulants for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents. The approval is based on results of a study of Intuniv when given in combination with a stimulant.
During the 9-week, multicenter, double-blind, randomized, placebo-controlled study, patients (N=455) experiencing a suboptimal response to stimulant treatment for ADHD received a morning or evening dose of Intuniv (1 mg, 2 mg, 3 mg, or 4 mg) or placebo in combination with their prescribed dose of a stimulant. Clinicians using the ADHD-RS-IV, which includes both hyperactive/impulsive and inattentive subscales, reported significant reductions in total scores from baseline at end point for patients receiving Intuniv and stimulant when Intuniv was dosed either in the morning or evening, compared with placebo and stimulant.
Commonly observed adverse reactions in this adjunctive trial were: somnolence, fatigue, insomnia, dizziness and abdominal pain. Events were mild or moderate in severity and no unique events were observed with Intuniv given with a stimulant compared with those reported historically for either treatment alone.