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Zulresso Postmarket Commitment Hints At Easier Dosing In Postpartum Depression

 
• By Derrick Gingery

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.

Mother stressed and tired with her hands over her face

Simplified dosing of Sage Therapeutics Inc.'s new postpartum depression treatment Zulresso remains a possibility, although likely several years away, pending the outcome of a post-marketing commitment.

Zulresso (brexanolone) became the first FDA-approved product indicated for postpartum depression with its approval March 19. Clearance is contingent on Drug Enforcement Agency scheduling, which has not been completed. The gamma-aminobutyric acid (GABAA) receptor is expected to be available in late June, but could launch sooner if the DEA decision arrives early, Sage said

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