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Psych Congress  
2017

Dasotraline for the Treatment of Moderate-to-Severe Binge Eating Disorder in Adults: Results from a Randomized, Double-Blind, Placebo-Controlled Study

Authors  
Bradford Navia, MD, PhD; James Hudson, MD, ScD; Susan McElroy, MD; Anna Guerdjikova, PhD, MSW, LISW; Ling Deng, PhD; Kaushik Sarma, MD; Seth Hopkins, PhD; Kenneth Koblan, PhD; Antony Loebel, MD; Robert Goldman, PhD
Sponsor  
Sunovion Pharmaceuticals Inc.

This poster was presented at the 30th annual  Psych Congress, held Sept. 16-19, 2017, in New Orleans, Louisiana.

Background

Binge eating disorder (BED) is the most common eating disorder with a US prevalence of 2.8%. This study evaluated dasotraline, a novel dopamine and norepinephrine reuptake inhibitor, in adults with moderate-to-severe BED over a 12-week period.

Methods

Patients with moderate-to-severe BED were randomized 1:1 to flexibly-dosed dasotraline (4/6/8 mg/day) or placebo. Primary endpoint was change from baseline (CFB) in number of binge eating (BE) days per week at Week 12. Key secondary endpoints included: CFB in CGI-S score at Week 12; CFB in YBOCS-BE at Week 12; percent subjects with 4-week BE cessation; and safety endpoints.

Results

Mean age of 317 ITT subjects was 38.2 years; 84% were female. At Week 12, CFB in the number of BE days per week was -3.74 for dasotraline and -2.75 for placebo, a significant mean difference of -0.99 (p<0.001; effect size 0.74) in favor of dasotraline. The dasotraline group also showed statistically significant improvements compared with placebo on all key secondary endpoints (all p<0.001). 46.5% of the dasotraline group achieved 4-week cessation from BE vs 20.6% of the placebo group. Most frequent TEAEs (dasotraline>placebo): insomnia (44.6% vs 8.1%), dry mouth (27.4% vs 5.0%), decreased appetite (19.7% vs 6.9%), anxiety (17.8% vs 2.5%), nausea (12.7% vs 6.9%), and decreased weight (12.1% vs 0%).

Conclusions

In adults with moderate-to-severe BED, dasotraline resulted in significant and clinically meaningful reductions versus placebo in frequency of binge eating; global severity of illness; and obsessive-compulsive symptoms related to binge eating. Dasotraline may offer a novel, well-tolerated and efficacious treatment for BED.

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