Supernus reports mixed Phase IIb data for ADHD product

Supernus Pharmaceuticals Inc. (NASDAQ:SUPN) reported that low- and mid-dose SPN-810 met one co-primary endpoint and missed another in a Phase IIb trial to treat impulsive aggression in patients with ADHD. Low- and mid-dose SPN-810 met the co-primary endpoint of improving the rate of remission of aggression as measured by the change from baseline in Retrospective - Modified Overt Aggression Scale (R-MOAS) scores after at least three weeks of treatment vs. placebo. Specifically, SPN-810 led to R-MOAS remission in 51.9% of patients in the low-dose group (p=0.009) and 40% of patients in the mid-dose group (p=0.043) vs. placebo. However, both doses of SPN-810 missed the co-primary endpoint of reducing R-MOAS scores from baseline vs. placebo. Specifically, SPN-810 reduced R-MOAS scores by 62.6% in the low-dose group (p=0.071) and 57.9% in the mid-dose group (p=0.115) vs. placebo. Supernus said that high-dose SPN-810 did not show significant efficacy across any endpoint. The double-blind Phase IIb trial enrolled 121 patients aged 6-12 with ADHD and impulsive aggression not controlled by optimal stimulant and psychosocial treatment. ...