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

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.

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...