Intuniv approved for ADHD

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.

For more information call (800) 536-7878 or visit www.intuniv.com.