Supernus Pharmaceuticals (NASDAQ:SUPN) is up 10% premarket on light volume in reaction to updated data from a Phase 3 clinical trial, P301, evaluating SPN-810 for the treatment of impulsive aggression (IA) in patients (ages 6 – 11 years) with attention deficit hyperactivity disorder (ADHD).
Topline results, first reported last month, showed a median 58.6% reduction in average weekly frequency of IA episodes from baseline compared to placebo. The separation, however, was not statistically significant (p=0.092).
The issue was an increase in variability in the 36 mg treatment arm due to six participants (out of 135) with mild IA conditions (seven with same were in the control arm). Excluding these, the separation was statistically valid (p=0.017).
Results from a second Phase 3, P302, based on a statistical plan excluding patients with mild IA, should be available next quarter.
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