Mixed results for dasotraline in adults with binge eating disorder

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 6mg/day versus the placebo-treated group.

However, said Sunovion Pharmaceuticals, a US subsidiary of Japanese pharma company Sumitomo Dainippon Pharma (TYO: 4506), the study did not meet its primary endpoint for the group treated with dasotraline 4 mg/day. 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).

‘May be an important new treatment option’