1. Pink Sheet

Sage's Brexanolone Could Be Transformative, But Only In Controlled Settings, US FDA Panel Says

 
• By Derrick Gingery

Advisory committee strongly favored approval of postpartum depression therapy, but many members suggest it should be administered in a facility with trained medical staff to avoid potential safety concerns.

FDA Advisory Committee Feature image

SAGE Therapeutics Inc.'s brexanolone could become a game-changing treatment for postpartum depression, but only if it is administered in a highly-controlled setting, US FDA advisory committee members said.

Members of the joint Psychopharmacologic Drugs and Drug Safety and Risk Management advisory committees gave an overwhelmingly positive recommendation of...

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