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 Friday, FDA's Psychopharmacologic Drugs Advisory Committee (PDAC) and Drug Safety and Risk Management (DSaRM) Advisory Committee are to discuss an NDA for brexanolone, a positive allosteric modulator (PAM) of GABA A receptor...