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Sage May Be Forced To Simplify Brexanolone Dosing Regimen

Executive Summary

Advisory committee members warned of dosing errors and other potential problems with the titration/taper regimen used in the clinical trials, arguing a simpler dosing schedule also could increase patient access.

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Zulresso Postmarket Commitment Hints At Easier Dosing In Postpartum Depression

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.

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