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Supernus Pharmaceuticals Inc Announces Positive Phase IIb Results on SPN-810 and Decision to Advance to Late Stage Development

Tuesday, 20 Nov 2012 08:07pm EST 

Supernus Pharmaceuticals Inc announced that it received positive topline results from its Phase IIb study on SPN-810 for the treatment of impulsive aggression in ADHD patients. The study is a multicenter randomized, double-blind, placebo controlled clinical trial in children 6 to 12 diagnosed with Attention Deficit and Hyperactivity Disorder (ADHD) and characterized by impulsive aggression that is not controlled by optimal stimulant and psychosocial treatment. A total of 121 patients were randomized in the study across placebo and three doses of SPN-810. The primary endpoints in the study were the effect in reducing impulsive aggression as measured with change in the score of the Retrospective - Modified Overt Aggression Scale "R-MOAS", and the rate of remission of aggression, after at least three weeks of treatment. Secondary endpoints included safety and tolerability of SPN-810 as well as the effect on the Clinical Global Impression and the Swanson, Nolan and Pelham Rating Scale (SNAP-IV) for ADHD. Patients who completed the study were offered the opportunity to continue into a six months open-label phase that is currently on-going. The study is a dose finding study with the primary objective of identifying effective doses in children of different weight groups. 

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