Posted by Michael Wonder on 31 Jul 2019
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
30 July 2019 - Binge eating disorder is estimated to affect 4.1 million Americans and may occur at a rate that is three times higher than anorexia and bulimia combined.
Sunovion Pharmaceuticals today announced that the U.S. FDA has accepted its New Drug Application (NDA) for dasotraline, a novel dopamine and norepinephrine re-uptake inhibitor (DNRI), for the treatment of patients with moderate-to-severe binge eating disorder (BED). Dasotraline’s pharmacokinetic profile, characterised by an extended half-life, supports its potential for sustained control of moderate-to-severe BED symptoms.
The action date by the FDA under the Prescription Drug User Fee Act is 14 May 2020.
Dasotraline is an investigational, once-daily medication that demonstrated significant efficacy for the treatment of moderate-to-severe BED in two 12-week, randomised, placebo-controlled studies, SEP360-221 and SEP360-321. Dasotraline was found to be generally well tolerated in clinical studies, including a long-term safety study, SEP360-322, that assessed patients with moderate-to-severe BED for up to one year.
