Efficacy and Safety of Dasotraline in Adults With Binge-Eating Disorder: A Randomized, Double-blind, Fixed-dose Trial

Background: In a previous flexible dose study, dasotraline, a long-acting dopamine/ norepinephrine reuptake inhibitor, demonstrated significant efficacy in the treatment of binge-eating disorder (BED). The aim of this confirmatory fixed-dose study was to evaluate efficacy and safety of dasotraline in BED patients.

Methods: Patients meeting DSM-5 criteria for BED were randomized to 12 weeks of double-blind treatment with dasotraline (4 mg/d or 6 mg/d), or placebo. The primary efficacy endpoint was change in number of binge-eating (BE) days per week at week 12. Secondary efficacy outcomes included the Binge Eating Clinical Global Impression of Severity Scale (BE-CGI-S) and the Yale-Brown Obsessive-Compulsive Scale Modified for Binge Eating (Y-BOCS-BE).

Results: In the ITT population (N=486), significant week 12 reduction in BE-days/week was observed for dasotraline 6 mg/d vs. placebo (-3.5 vs. -2.9; P=0.0045), but not for the 4 mg/d dose (-3.2; P=0.118). Greater improvement was observed vs. placebo for dasotraline 6 mg/d and 4 mg/d, respectively, on the BE-CGI-S (nominal P=0.003 and P=0.026) and the Y-BOC-BE (nominal P= < 0.001 and P=0.015) (not adjusted for multiplicity). The most common adverse events on dasotraline 6 mg/d and 4 mg/d were insomnia, dry mouth, headache and decreased appetite.

Conclusions: In this 12-week study, treatment with dasotraline 6 mg/d was associated with a significant reduction in binge-eating days per week; efficacy was not demonstrated for the 4 mg dose. Treatment with both doses of dasotraline resulted in improvement in the Y-BOCS-BE and the BE-CGI-S. Dasotraline was safe and generally well-tolerated at both doses.

This poster was presented at the 32nd annual Psych Congress, held Oct. 3-6, 2019, in San Diego, California.