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FDA Approves INTUNIV® (guanfacine) Extended-Release Tablets for Use as Adjunctive Therapy to Stimulants for the Treatment of ADHD in Children and Adolescents
Date:2/28/2011

onal, and social).(1)

INTUNIV is the only once-daily ADHD medication approved for administration as adjunctive therapy to stimulants. INTUNIV, a nonstimulant, is a selective alpha-2A agonist.(1)

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.(2)  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.(2)

Suboptimal response was defined as treatment with a stable dose of stimulant for at least four weeks with improvement, yet persistence of mild to moderate ADHD symptoms in the opinion of the investigator (defined as an ADHD-RS-IV total score of at least 24, Clinical Global Impressions-Severity of Illness scale score of at least three). Patients with no response to stimulants prior to study enrollment were excluded from participating in this study.(2)

The most commonly observed adverse reactions (incidence greater than or equal to 5 percent and at least twice the rate for placebo) in this adjunctive trial were: somnolence, fatigue, insomnia, dizziness, and abdominal pain.(1)  The majority of 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.(2)  Three percent of patients receiving INTUNIV plus stimulant discontinued from the study due to adverse events, compared to 1 percent in the placebo plus stimulant group.(1)

Four serious adverse events (SAEs) were reported in the study a
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