Results from a pivotal Phase 3 study evaluating the use of dasotraline (Sunovion) in adult patients with binge eating disorder showed that the novel dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) was effective at reducing the number of binge days per week.
In this 12-week double-blind, parallel-group, multicenter, fixed-dose study, patients with moderate to severe binge eating disorder were randomized to receive once-daily doses of dasotraline 4mg, dasotraline 6mg, or placebo. Change from baseline in number of binge days (defined as days during which at least 1 binge episode occurs) per week at Week 12 was chosen as the primary outcome, while secondary endpoints included change from baseline in the Binge Eating Clinical Global Impression-Severity score (BE-CGI-S) at Week 12, change from baseline in the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) total score at Week 12, and percent of subjects with a 4-week cessation in binge eating prior to Week 12 or the end of study visit.
Compared with placebo, dasotraline 6mg/day was found to be statistically significantly associated with a decrease in the number of binge days per week, however, dasotraline 4mg/day did not meet the primary endpoint. Statistically significant improvements in both BE-CGI-S score and Y-BOCS-BE total score were observed in both dasotraline groups.
“These study results suggest that dasotraline may be an important new treatment option for adults with [binge eating disorder], which is encouraging news and provides hope for patients with this difficult disorder,” said Susan L. McElroy, MD, Chief Research Officer at Lindner Center of HOPE, Professor of Psychiatry and Behavioral Neuroscience at the University of Cincinnati College of Medicine.
The results from this trial follow similar positive findings from a flexible-dose study of dasotraline. Data from both of these trials will be presented at a future scientific congress.
Dasotraline is also being investigated as a potential treatment for attention deficit hyperactivity disorder (ADHD) in children, adolescents, and adults. The Food and Drug Administration (FDA) has accepted for review the New Drug Application and has set a Prescription Drug User Fee Act date of August 30, 2018 for this indication.
For more information visit Sunovion.US.