FDA News

FDA accepts New Drug Application for binge eating disorder treatment

Antony Loebel, MD
Antony Loebel

The FDA has accepted Sunovion Pharmaceuticals’ New Drug Application for dasotraline, a novel dopamine and norepinephrine reuptake inhibitor, for the treatment of patients with moderate-to-severe binge eating disorder, according to a press release.

Dasotraline, an investigational, once-daily medication with a pharmacokinetic profile characterized by an extended half-life, has shown significant efficacy for the treatment of moderate-to-severe binge eating disorder in two 12-week, randomized, placebo-controlled studies, known as SEP360-221 and SEP360-321, according to the release. In addition, dasotraline was generally well-tolerated in clinical studies, including a long-term safety study, which examined patients with binge eating disorder for up to 1 year.

The Prescription Drug User Fee Act (PDUFA) date is May 14, 2020, according to the release.

“Binge eating disorder is a serious mental health condition for which limited treatment options exist. 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 under-diagnosed and under-treated,” Antony Loebel, MD, president and CEO at Sunovion, said in the release. “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.”

Antony Loebel, MD
Antony Loebel

The FDA has accepted Sunovion Pharmaceuticals’ New Drug Application for dasotraline, a novel dopamine and norepinephrine reuptake inhibitor, for the treatment of patients with moderate-to-severe binge eating disorder, according to a press release.

Dasotraline, an investigational, once-daily medication with a pharmacokinetic profile characterized by an extended half-life, has shown significant efficacy for the treatment of moderate-to-severe binge eating disorder in two 12-week, randomized, placebo-controlled studies, known as SEP360-221 and SEP360-321, according to the release. In addition, dasotraline was generally well-tolerated in clinical studies, including a long-term safety study, which examined patients with binge eating disorder for up to 1 year.

The Prescription Drug User Fee Act (PDUFA) date is May 14, 2020, according to the release.

“Binge eating disorder is a serious mental health condition for which limited treatment options exist. 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 under-diagnosed and under-treated,” Antony Loebel, MD, president and CEO at Sunovion, said in the release. “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.”