The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for dasotraline (Sunovion) in the treatment of binge eating disorder.
Dasotraline is a novel dopamine and norepinephrine reuptake inhibitor. The NDA is supported by data from two phase 2/3 studies and a long term safety study. Both the SEP360-221 and SEP360-321 trials were 12-week, randomized placebo controlled studies that evaluated dasotraline in patients with moderate to severe binge eating disorder.
Results from SEP360-221 showed that at week 12, treatment with dasotraline was associated with a significant difference in change from baseline in the number of binge eating days per week, compared with placebo (P <.0001) with an effect size (ES) of 0.74; 46.5% of patients in the dasotraline group achieved ≥4 consecutive weeks cessation of binge eating vs 20.6% in the placebo group (P <.0001).
In SEP360-321, dasotraline 6mg/day was found to be statistically significantly associated with a decrease in the number of binge days per week, however, dasotraline 4mg/day did not meet the primary endpoint.
Following completion of SEP360-321, patients were able to enroll in a 12-month, open label extension study (SEP360-322) to evaluate the long term safety and tolerability of dasotraline; the treatment was found to be generally well-tolerated in this patient population.
The FDA has set a Prescription Drug User Fee Act (PDUFA) date of May 14, 2020 for the application. “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,” said Antony Loebel, MD, CEO at Sunovion.
Dasotraline is also being investigated in the treatment of attention deficit hyperactivity disorder (ADHD). Last year, the FDA issued a Complete Response Letter to Sunovion stating that the dasotraline NDA could not be approved in its current form and that additional data were required to further assess the efficacy and tolerability of the drug in ADHD.
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