FDA Reviewers: REMS could allay safety concerns for Sage's brexanolone

FDA reviewers proposed implementing a REMS to address loss-of-consciousness events associated with brexanolone (SAGE-547) from Sage Therapeutics Inc. (NASDAQ:SAGE) to treat postpartum depression (PPD), according to a briefing document issued ahead of a joint advisory committee meeting.

On Nov. 2, FDA's Psychopharmacologic

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