Dasotraline treatment safe, efficacious for binge-eating disorder
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Dasotraline appeared safe, efficacious and generally well-tolerated for treating binge-eating disorder, according to results of a randomized, placebo-controlled, flexible-dose clinical trial published in Journal of Clinical Psychiatry.
“Binge-eating disorder is the most common eating disorder in the United States, and opportunities still exist to improve outcomes for people living with this serious condition,” Bradford Navia, MD, PhD, of Sunovion Pharmaceuticals Inc., told Healio Psychiatry. “These results show that flexibly dosed dasotraline of 4 to 8 mg per day demonstrated statistically significant and clinically meaningful improvement compared with placebo on the primary endpoint, which was change from baseline in the number of binge eating days per week at week 12. Dasotraline was generally well-tolerated.”
Because few evidence-based treatments exist for this disorder, Navia and colleagues aimed to evaluate the safety and efficacy of flexibly dosed dasotraline, a novel dopamine and norepinephrine reuptake inhibitor, among an intent-to-treat sample of 315 adults with a DSM-5 diagnosis of moderate to severe binge-eating disorder. The investigators randomly assigned participants to 12 weeks of double-blind treatment with once daily 4, 6, or 8 mg doses of dasotraline or placebo. Diary-based assessment of number of weekly binge-eating days at 12 weeks served as the primary endpoint. Changes from baseline in Clinical Global Impressions-Severity of Illness scale (CGI-S) and Yale-Brown Obsessive Compulsive Scale Modified for Binge-Eating (YBOS-BE), as well as percentage of subjects with binge eating cessation in the final 4 weeks, served as key secondary endpoints.
Results showed a significantly greater reduction in weekly binge-eating days at study endpoint associated with treatment with dasotraline vs. placebo. Navia and colleagues observed significant endpoint improvement for CGI-S (P < .0001), YBOCS-BE (P <. 0001) and 4-week binge eating cessation (46.5% vs. 20.6%; P < .0001). The most frequent adverse events related to treatment with dasotraline included insomnia, dry mouth, decreased appetite, anxiety, nausea, decreased weight and headache. Discontinuation related to adverse events occurred among 11.3% of patients in the dasotraline group vs. 2.5% in the placebo group.
“The flexible-dose design of the current trial did not permit evaluation of dose-response effects; given this uncertainty, the lowest effective dose should be utilized to minimize adverse effects,” Navia and colleagues wrote. “Further investigation is needed to establish the longer-term efficacy and safety of dasotraline beyond 12 weeks of treatment.”