Sunovion Pharmaceuticals, Inc. announced positive results of a pivotal phase 2/3 study (SEP360-221) that evaluated the efficacy and safety of dasotraline in adults between the ages of 18 and 55 years with moderate to severe binge eating disorder (BED), according to research presented at the American Psychiatric Association (APA) 2017 Annual Meeting, held May 20-24 in San Diego, California.
Dasotraline, a dopamine and norepinephrine reuptake inhibitor (DNRI), evidenced significant reductions in the frequency of binge eating days per week vs placebo and “was generally well tolerated with an adverse event profile consistent with completed adult studies,” Antony Loebel, MD, executive vice president and chief medical officer at Sunovion, and head of Global Clinical Development for Sumitomo Dainippon Pharma Group, said in an interview with Psychiatry Advisor.
“We are encouraged by these results suggesting that dasotraline may offer a novel, well-tolerated and efficacious treatment for [BED],” Dr Loebel added. “Limited treatment options are available for this challenging illness.”
The pivotal study enrolled 317 adults (84.1% female) with moderate to severe BED in a 12-week, randomized, double-blind, parallel-group, multicenter, placebo-controlled, flexible-dosed (4-8 mg/day) study comparing dasotraline with placebo. (Dr Loebel described moderate to severe BED as ≥2 binge eating days/week for ≥6 months before screening and ≥3 binge eating days/week for each of the 2 weeks before baseline.)
The primary endpoint was the change from baseline in number of binge eating days (defined as days during which at least 1 binge episode occurs) per week at week 12. Secondary efficacy endpoints included Clinical Global Impression of Severity of Illness Scale, the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating, and percentage of subjects with 4-week cessation from binge eating.
“Dasotraline was generally well tolerated with an adverse event profile consistent with completed adult studies,” Dr Loebel said. The adults in the study experienced statistically significant and clinically meaningful improvement compared with placebo on the primary endpoint, change from baseline in the number of binge eating days per week at week 12 (P <.0001), with an effect size of 0.74.
“The results indicate dasotraline may offer a novel, effective and well-tolerated treatment option for adults with moderate to severe BED,” Dr Loebel said. “In order to confirm the efficacy and safety of dasotraline for the treatment of BED, a second pivotal trial is underway.”
Sunovion Announces Positive Results from Pivotal Study Evaluating Novel Drug Candidate Dasotraline in Adults with Binge Eating Disorder at Annual American Psychiatric Association Meeting. http://www.businesswire.com/news/home/20170523005465/en/Sunovion-Announces-Positive-Results-Pivotal-Study-Evaluating. Published May 23, 2017. Accessed May 31, 2017.