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BRIEF-Sage Therapeutics announces Brexanolone achieves primary endpoints
2017年11月9日 / 上午11点17分 / 14 天前

BRIEF-Sage Therapeutics announces Brexanolone achieves primary endpoints

Nov 9 (Reuters) - Sage Therapeutics Inc:

* Announces Brexanolone achieves primary endpoints in both phase 3 clinical trials in postpartum depression

* Statistically significant mean reduction in HAM-D score compared to placebo at 60 hours demonstrated in both trials​

* Brexanolone was generally well tolerated and showed a similar safety profile as seen in earlier studies​

* Brexanolone achieved primary endpoint in both trials​

* In each trial, 1 patient experienced serious adverse event; neither required hospitalization, 1 deemed not to be study-drug related​

* Sage plans to file a New Drug Application (NDA) with U.S. Food and Drug Administration in 2018 for Brexanolone​ Source text for Eikon: Further company coverage:

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