Sunovion Pharmaceuticals Inc. (Sunovion) today announced that a study (SEP360-321) evaluating the efficacy and safety of dasotraline in adults (18 to 55 years of age) with moderate to severe binge eating disorder (BED) met its primary endpoint, demonstrating a statistically significant decrease in number of binge days per week (defined as days per week during which at least one binge episode occurs) from baseline to Week 12 in the group treated with dasotraline 6 mg/day versus the placebo-treated group. The study did not meet its primary endpoint for the group treated with dasotraline 4 mg/day. For both dasotraline dose groups, statistically significant improvement was demonstrated compared to placebo treatment in the Binge Eating Clinical Global Impression-Severity (BE-CGI-S) score and the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) total score (these results reflect secondary efficacy analyses without control for multiplicity).
"Binge eating disorder is associated with significant challenges for patients, ranging from marked distress and depression, to chronic health issues including heart disease and type 2 diabetes," said Susan L. McElroy, M.D., Chief Research Officer at Lindner Center of HOPE, Professor of Psychiatry and Behavioral Neuroscience at the University of Cincinnati College of Medicine. "These study results suggest that dasotraline may be an important new treatment option for adults with BED, which is encouraging news and provides hope for patients with this difficult disorder."
Dasotraline, a novel dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI), was generally well tolerated in both dose groups. The rate of study discontinuation due to adverse events in the dasotraline 4 mg/day, 6 mg/day and placebo-treatment groups was 8.6 percent, 14.1 percent and 1.2 percent, respectively. The most common (≥10 percent) adverse events in either dasotraline dose group were insomnia, dry mouth, headache, decreased appetite, nausea and anxiety, consistent with previous dasotraline studies.
In the previous pivotal study (SEP360-221), flexibly dosed dasotraline 4-8 mg/day demonstrated statistically significant improvement at the 12-week primary endpoint on the change from baseline in number of binge days per week compared to the placebo-treated group. Additionally, dasotraline was associated with statistically significant improvement in the BE-CGI-S score, the Y-BOCS-BE total score and the percent of subjects with four-week cessation from binge eating. Sunovion announced top-line results from study SEP360-221 on January 13, 2017 and additional results on May 23, 2017 at the American Psychiatric Association Meeting.
"While binge eating disorder is the most common eating disorder in the U.S., few approved treatment options are available," said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma Group. "We're encouraged by the positive top-line results of flexible-dose study SEP360-221, and now fixed-dose study SEP360-321, which taken together suggest that dasotraline may provide an important new treatment option for people with binge eating disorder."
Following completion of study SEP360-321, patients had the option to enroll in a currently ongoing 12-month, open-label extension study (SEP360-322), evaluating the long-term safety and tolerability of dasotraline in the treatment of BED.
BED is characterized by recurrent episodes of binge eating that occur at least once per week for three months and was officially recognized by the American Psychiatric Association in the Diagnostic and Statistical Manual of Mental Disorders (DSM), Fifth Edition, in 2013.
Data from SEP360-321 and SEP 360-221 will support submission of a marketing application for dasotraline to treat moderate to severe binge eating disorder in adults in the U.S. in FY2018. Full results are being analyzed and will be presented at a future scientific congress.
In August 2017, Sunovion submitted a New Drug Application (NDA) for dasotraline for the treatment of attention deficit hyperactivity disorder (ADHD) in children, adolescents and adults. In November 2017, the U.S. Food and Drug Administration (FDA) accepted the NDA for review, with a PDUFA date set for August 30, 2018.