Phase III SEP360-321 trial of dasotraline meets primary endpoint in binge eating disorder.- Sunovion Pharma.

Sunovion Pharmaceuticals announced that a study (SEP360-321) evaluating the efficacy and safety of dasotraline in adults (18 to 55 years of age) with moderate to severe binge eating disorder (BED) met its primary endpoint, demonstrating a statistically significant decrease in number of binge days per week (defined as days per week during which at least one binge episode occurs) from baseline to Week 12 in the group treated with dasotraline 6 mg/day versus the placebo-treated group. The study did not meet its primary endpoint for the group treated with dasotraline 4 mg/day.

SEP360-321 was a Phase III, 12-week, randomized, double-blind, parallel-group, multi-center, placebo-controlled, fixed-dose study comparing dasotraline versus placebo in adults 18 to 55 years of age with moderate to severe BED. For both dasotraline dose groups, statistically significant improvement was demonstrated compared to placebo treatment in the Binge Eating Clinical Global Impression-Severity (BE-CGI-S) score and the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) total score (these results reflect secondary efficacy analyses without control for multiplicity).

Dasotraline was generally well tolerated in both dose groups. The rate of study discontinuation due to adverse events in the dasotraline 4 mg/day, 6 mg/day and placebo-treatment groups was 8.6 percent, 14.1 percent and 1.2 percent, respectively. The most common (at least 10 percent) adverse events in either dasotraline dose group were insomnia, dry mouth, headache, decreased appetite, nausea and anxiety, consistent with previous dasotraline studies. Data from SEP360-321 and SEP 360-221 will support submission of a marketing application for dasotraline to treat moderate to severe binge eating disorder in adults in the U.S. in FY2018. Full results are being analyzed and will be presented at a future scientific congress.