Supernus Pharmaceuticals announced positive results from its Phase 2a study of SPN-812 in adults for the treatment of attention deficit hyperactivity disorder. This was a randomized, double-blind, placebo-controlled trial in 52 adults with a current diagnosis of ADHD. The study met the primary endpoints of safety and tolerability, and showed statistically significant median reduction versus placebo in both investigator-rated and patient-rated ADHD symptom scores, measured by Total ADHD Symptom Score on the Conners’ Adult ADHD Rating Scale, or CAARS.
The effectiveness of SPN-812 when compared with placebo was determined by changes in the Clinical Global Impressions-Improvement (CGI-I) score. Subjects in the active group achieved overall significant median reductions from baseline in investigator-rated CAARS total ADHD symptom scores by study end: -11.5 points vs. -6.0 for placebo (p=0.0414); and in self-rated CAARS total symptom scores by study end: -10.5 points vs. -1.0 for placebo (p=0.0349). With respect to the secondary endpoint of CGI-I scores, patients exhibited a trend, although not statistically significant, toward larger median reductions in scores from baseline vs. placebo.
SPN-812 is an antidepressant selective norepinephrine reuptake inhibitor.
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