Supernus announces positive Phase 2b results on SPN-810, advances to development Supernus Pharmaceuticals received positive top-line results from its Phase 2b study on SPN-810 for the treatment of impulsive aggression in ADHD patients. The study is a multi-center randomized, double-blind, placebo controlled clinical trial in children 6-12 diagnosed with Attention Deficit and Hyperactivity Disorder, or 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. SPN-810 was well tolerated throughout the study across all doses. The two serious adverse events that occurred were not drug related. The company will be analyzing the full data-set in depth, and subsequently planning on meeting with the FDA to discuss next steps in the development program and the design and protocol for Phase III clinical trials.
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