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BioWorld - Wednesday, May 20, 2026
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Home » Sage in the spotlight as brexanolone faces joint adcom panel in PPD
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Sage in the spotlight as brexanolone faces joint adcom panel in PPD

Nov. 1, 2018
By Marie Powers
Sage Therapeutics Inc. becomes the second biopharma this week to face a joint meeting of the FDA's Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee, which on Friday will review efficacy and safety data from the NDA for lead candidate brexanolone in the initial indication of postpartum depression (PPD). If the agency's briefing documents are a guide, the discussion is likely to focus on loss of consciousness (LOC) events that occurred during the drug's development program and the appropriate setting to administer the type A gamma-aminobutyric acid (GABAA) receptor modulator, which requires a 60-hour infusion.
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