FDA accepts dasotraline NDA for binge-eating disorder


The Food and Drug Administration has accepted the new drug application for dasotraline for the treatment of moderate to severe binge-eating disorder, the drug’s developer, Sunovion, announced July 30.

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Dasotraline, a dopamine and norepinephrine reuptake inhibitor, demonstrated significant efficacy in a pair of 12-week, randomized, placebo-controlled studies (SEP360-221 and SEP360-321). The drug also was found to be well tolerated by patients with binge-eating disorder (BED), both in those studies and in a long-term safety study that followed patients for up to a year (SEP360-322).

The medication – characterized by an extended half-life – is to be taken once a day. The most common adverse events reported by patients who took dasotraline include insomnia, dry mouth, decreased appetite, anxiety, nausea, and decreased weight.

BED is more common than any other eating disorder, with an estimated lifetime prevalence among U.S. adults of 1.25% for women and 0.42% for men (CNS Spectr. 2019 Jun 14. doi: 10.1017/S109285291900103). The condition also might run in families. BED often is comorbid with other psychiatric and behavioral disorders, such as depression, substance use, and PTSD, noted Antony Loebel, MD, president and CEO of Sunovion, in a press release. He also said BED often is underrecognized and undertreated.

Meta-analytic reviews show that cognitive-behavioral therapy is considered first-line treatment for BED. However, limited access to such psychological treatments makes the development of medication options such as dasotraline important.

Last year, the agency rejected a new drug application for dasotraline for the treatment of ADHD, citing a need for additional data. The action date by the FDA on dasotraline for BED is May 14, 2020, Sunovion reported.

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