The US Food and Drug Administration (FDA) has accepted a New Drug Application for dasotraline for the treatment of patients with moderate-to-severe binge eating disorder, Sunovion Pharmaceuticals Inc. recently announced.
Dasotraline is novel dopamine and norepinephrine reuptake inhibitor which demonstrated significant efficacy for the treatment of moderate-to-severe binge eating disorder in a pair of 12-week, double-blind, placebo-controlled studies.
In the SEP360-221 study, adult patients were randomized to once-daily 4 mg to 8 mg of dasotraline or placebo. Dasotraline was statistically superior to placebo on the primary efficacy endpoint of change from baseline in number of binge days per week at week 12.
In the SEP360-321 study, participants were randomized to once-daily dasotraline 4 mg, dasotraline 6 mg, or placebo. That study also met its primary efficacy endpoint and demonstrated a significant drop in the number of binge days per week at week 12 in patients treated with dasotraline 6 mg/day, compared with patients treated with placebo.
Dasotraline was generally well tolerated in both studies, as well as in the long-term safety study SEP360-322, which assessed patients for up to 1 year.
“Binge eating disorder is a serious mental health condition for which limited treatment options exist,” said Sunovion president and chief executive officer Antony Loebel, MD, in a press release. “The disorder is often seen in association with other behavioral conditions such as depression, substance abuse, and post-traumatic stress disorder, and it is often underdiagnosed and undertreated.”
“We are confident in the value dasotraline has shown in clinical trials to people living with binge eating disorder and look forward to working with the FDA to advance this novel treatment option.”
The action date by the FDA under the Prescription Drug User Fee Act is May 14, 2020, according to Sunovion.
Sunovion announces acceptance by the U.S. FDA of the New Drug Application for dasotraline for the treatment of adults with moderate-to-severe binge eating disorder [press release]. Marlborough, Massachusetts: Sunovion Pharmaceuticals Inc.; July 30, 2019.