Sunovion's high-dose dasotraline meets primary in Phase III for binge eating disorder

The Sunovion Pharmaceuticals Inc. subsidiary of Sumitomo Dainippon Pharma Co. Ltd. (Tokyo:4506) said the once-daily 6 mg dose of dasotraline (SEP-225289) met the primary endpoint of reducing the number of binge days, defined as days during which ≥1 binge episode occurs, per week at week 12 vs. placebo in the Phase III SEP360-321 trial to treat binge eating disorder. The once-daily 4 mg dose of dasotraline missed the endpoint.

On secondary endpoints, both doses of dasotraline significantly improved Binge Eating Clinical Global Impression-Severity (CGI-S) and Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) scores from baseline to week 12 vs. placebo...