The FDA has approved once-daily Intuniv (guanfacine extended-release tablets, from Shire), a selective alpha-2A adrenergic receptor agonist, for the treatment of attention-deficit hyperactivity disorder (ADHD) in children and adolescents 6–17 years of age. This approval was based on results from two similarly designed, placebo-controlled clinical trials in patients 6–17 years of age who met Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria for ADHD. Both trials demonstrated statistically significant improvements in ADHD-Rating Scale (RS)-IV scores in patients taking Intuniv beginning 1–2 weeks after patients began receiving once-daily doses of Intuniv. In the first trial, the mean reduction in ADHD-RS-IV total scores from baseline to the endpoint were -16.7 for Intuniv compared to -8.9 for placebo (p<.0001). The mean reduction in ADHD-RS-IV total scores in the second trial were -19.6 for Intuniv and -12.2 for placebo (p=0.004). Significant improvements were also observed in secondary efficacy outcome measures, which included the Conners’ Parent Rating Scale-Revised: Short Form (CPRS-R) and the Conner’s Teacher Rating Scale-Revised: Short Form (CTRS-R) that use parent/teacher observer and self-reported ratings to help assess ADHD.

Intuniv is not a controlled substance and has no known potential for drug abuse or dependence. Intuniv is expected to be made available in November 2009 in 1mg, 2mg, 3mg, and 4mg dosage strengths.

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