Sunovion tries again with new dasotraline filing in USA

30 July 2019

Sunovion Pharmaceuticals, a subsidiary of Japan's Sumitomo Dainippon (TYO: 4506), has announced that the US regulator will review its novel treatment option dasotraline, for moderate-to-severe binge eating disorder (BED).

The application is based on results from the SEP360-321 study, announced in the latter part of 2018, which showed a statistically-significant decrease in number of binge days per week, at the higher dose.

The US Food and Drug Administration earlier rejected an application from the firm to market the drug for the treatment of attention-deficit hyperactivity disorder (ADHD).

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