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.
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The latest drug development news and highlights from our US FDA Performance Tracker.
US FDA wants Sage Therapeutics to explore Zulresso use in alternative settings in a postmarketing trial. A successful study could expand access to the new approved brexanolone, whose administration is now long, complicated, and restricted to certified healthcare facilities.
I.V. Zulresso is the first US FDA-approved drug for postpartum depression (PPD) and Sage's first commercial product – with a list price of $34,000. It will help the company build a presence in PPD as it completes late-stage development for oral candidate SAGE-217.