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Psych Congress  

Dasotraline for Treatment of Adults With Binge-Eating Disorder: Effect on Binge-related Obsessions and Compulsions


Leslie Citrome, MD – New York Medical College, Valhalla, NY; Ling Deng, PhD – Sunovion Pharmaceuticals Inc.; Robert Goldman, PhD – Sunovion Pharmaceuticals Inc.; Todd Grinnell, BA – Sunovion Pharmaceuticals Inc.; Andrei Pikalov, MD, PhD – Sunovion Pharmaceuticals Inc.; Joyce Tsai, PhD – Sunovion Pharmaceuticals Inc.

Sunovion Pharmaceuticals Inc.

Background: In a previous study, dasotraline, a long-acting dopamine/norepinephrine reuptake inhibitor, demonstrated efficacy in the treatment of binge-eating disorder (BED). We now report an analysis from this study of the effect of dasotraline on binge-related obsessions and compulsions.

Method: Patients with moderate-to-severe BED, based on DSM-5 criteria, were randomized to 12 weeks of double-blind, placebo controlled, flexibly-dosed treatment with flexible doses of dasotraline (4, 6, and 8 mg/d). The primary efficacy measure was number of binge-eating days/week; the Yale-Brown Obsessive-Compulsive Scale Modified for Binge-Eating (Y-BOCS-BE) was included as a secondary measure.

Results: The ITT population consisted of 317 patients (female, 84%; mean age, 38.2 years). LS mean reduction from baseline in number of Binge Eating (BE) days per week was significantly greater for dasotraline vs. placebo at week 12 (-3.74 vs. -2.75; P < 0.0001; effect size [ES] = 0.74; primary endpoint); week 12 change was significantly greater for dasotraline vs. placebo on the Y-BOCS-BE total score (-17.05 vs. -9.88; P < 0.0001; ES, 0.96), the obsession subscale score (-8.32 vs. -4.58; P < 0.0001; ES, 0.95), and the compulsion subscale score (-8.69 vs. -5.35; P < 0.0001; ES, 0.87). All 10 YBOCS-BE items were significantly improved on dasotraline vs. placebo at week 12 (P < 0.001 for all comparisons; effect sizes: 0.54 to 0.90).

Conclusion: In this placebo-controlled, 12-week study of patients with moderate-to-severe binge eating disorder, treatment with dasotraline (4-8 mg/d) was associated with significant and clinically meaningful reduction in binge-related obsessional thoughts and compulsive behaviors.

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

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