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FDA documents hint at ‘uphill battle’ for broad approval of Sage’s depression drug

September 1, 2023


The Food and Drug Administration’s decision last month not to approve a new treatment for one of the most common forms of depression was, in part, due to safety concerns, according to newly released documents detailing the agency’s review process.

The treatment, now known as Zurzuvae, was developed by Massachusetts-based biotechnology company Sage Therapeutics. Through a series of late-stage clinical trials, Sage tested Zurzuvae as a potential therapy for both postpartum depression and major depressive disorder. Results from the postpartum study were generally positive, showing the medicine quickly and significantly improved depressive symptoms.

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