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ARTICLE | Clinical News

Dasotraline: Ph III SEP360-301 data

January 20, 2017 9:32 PM UTC

Sumitomo Dainippon’s Sunovion Pharmaceuticals Inc. subsidiary reported top-line data from the double-blind, U.S. Phase III SEP360-301 trial in about 636 adults with ADHD showing that once-daily 4 and 6 mg doses of dasotraline both missed the primary endpoint of improving ADHD-RS-IV with adult prompts total score from baseline to week 8 vs. placebo (p=0.074 for high-dose dasotraline compared to placebo). The company said there was a "relatively large" improvement on the primary endpoint in the placebo arm. High-dose dasotraline did meet the secondary endpoint of improving CGI-S score from baseline to week 8 vs. placebo (p=0.011)...

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Sumitomo Pharma Co. Ltd.