Sunovion's SEP-363856 meets in Phase II for schizophrenia
Sunovion Pharmaceuticals Inc. and partner PsychoGenics Inc. (Paramus, N.J.) said SEP-363856 met the primary endpoint in the Phase II SEP361-201 trial to treat hospitalized patients with acute exacerbations of schizophrenia.
On the primary endpoint, SEP-363856 significantly reduced Positive and Negative Syndrome Scale (PANSS) total score from baseline to week four vs. placebo (17.2 vs. 9.7 points, p=0.001). SEP-363856 also met the secondary endpoints of improving Clinical Global Impression-Severity (CGI-S) score (p<0.001), PANSS positive and negative subscale scores (p=0.019 and p=0.008, respectively) and PANSS general psychopathology subscale score (p<0.001) from baseline to week four vs. placebo. The double-blind, international trial enrolled 245 patients to receive placebo or once-daily oral SEP-363856. Data were presented at the American College of Neuropsychopharmacology meeting in Hollywood, Fla...