168 Effect of Dasotraline on Body Weight in Patients with Binge-Eating Disorder.

BACKGROUND: Binge-eating disorder (BED) is associated with obesity (BMI >/=30) in approximately 40-45% of patients. Dasotraline is a long-acting dopamine/norepinephrine reuptake inhibitor with a PK profile characterized by slow absorption and an elimination half-life of 47-77 hours, permitting once-daily dosing. In a recent placebo-controlled, flexible-dose study, dasotraline demonstrated significant efficacy in patients with BED. We now report an analysis from this study of the effect of dasotraline on body weight. METHOD: Patients with moderate-to-severe BED, based on DSM-5 criteria, were randomized to 12 weeks of double-blind flexible-dose treatment with dasotraline (4-8 mg/d) vs. placebo. The primary efficacy outcome was number of binge-eating days/week. Mean change in body weight at Week 12 (assessed as a safety outcome) was analyzed by baseline body mass index (BMI, kg/m2) category. Inferential statistics were not performed. RESULTS: The safety population consisted of 317 patients (female, 84%; mean age, 38.2 years; mean weight, 97.3 kg). At baseline, the proportions of patients in each BMI category were as follows: normal ( /=40 kg/m2: 21.8%). For the overall patient sample, treatment with dasotraline significantly reduced the number of binge-eating days per week vs. placebo (-3.74 vs. -2.75; P /=5%) was observed in 45.3% of patients (vs. 4.1% on placebo); and weight reduction >/=10% in approximately 13.7% of patients (vs. none on placebo). Weight-related adverse events, for dasotraline vs. placebo, consisted of decreased appetite (19.7% vs. 6.9%), decreased weight (12.1% vs. 0%), and increased weight (0.6% vs. 1.3%). CONCLUSION: Among patients completing 12 weeks of treatment with dasotraline, weight reduction >/=5% was observed in 45% of obese patients with a BMI >/=30. The most frequent weight-related adverse event was decreased appetite, reported in approximately one in five patients treated with dasotraline.Clinicaltrials.gov number: NCT02564588. FUNDING ACKNOWLEDGEMENTS: Supported by funding from Sunovion Pharmaceuticals Inc.