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FDA Approves Once-Daily Guanfacine XR for ADHD in Children, Adolescents NEW YORK -- September 3, 2009 -- The US Food and Drug Administration (FDA) has approved guanfacine (Intuniv) extended release tablets for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years. The efficacy of guanfacine in the treatment of ADHD was established in 2, similarly designed, placebo-controlled clinical trials in children and adolescents aged 6 to 17 years who met Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria for ADHD. The first pivotal trial was a phase 3, double-blind, parallel-group trial, in which investigators randomised 345 children aged 6 to 17 years to either a placebo or guanfacine 2 mg, 3 mg or 4 mg given once daily during an 8-week period. The second trial was a phase 3, double-blind, parallel-group trial, in which investigators randomised 324 children aged 6 to 17 years to either a placebo or guanfacine 1 mg, 2 mg, 3 mg or 4 mg given once daily during a 9-week period, with the 1 mg assigned only to patients weighing less than 50 kg (110 lbs). In both trials, doses were increased in increments of 1 mg per week, and investigators evaluated participants' signs and symptoms of ADHD on a once-weekly basis using the clinician administered and scored ADHD Rating Scale-IV (ADHD-RS-IV). The primary outcome was the change in total ADHD-RS-IV scores from baseline to end point in both studies. In the first trial, the mean reduction in ADHD-RS-IV total scores at end point were -16.7 for guanfacine compared with -8.9 for placebo (P < .0001). The mean reduction in ADHD-RS-IV total scores in the second trial were -19.6 for guanfacine and -12.2 for placebo (P = .0040). Placebo-adjusted LS mean changes from baseline were statistically significant for all guanfacine doses in the randomised treatment groups in both studies. Additional secondary efficacy outcome measures included the Conners' Parent Rating Scale-Revised: Short Form (CPRS-R) and the Conners' Teacher Rating Scale-Revised: Short Form (CTRS-R). Based on the CPRS-R, parents reported significant improvement across a full day, and based on the CTRS-R, which was used only in the first trial, teachers reported significant improvement throughout the school day. Treatment-related adverse events included somnolence, headache, fatigue, upper abdominal pain, sedation, dizziness, hypotension, dry mouth, and constipation. SOURCE: Shire E-mail this page to a friend or colleague! To print, use this version