Sage's Postpartum Depression Drug Brexanolone Faces Loss-Of-Consciousness Questions
US FDA is recommending a REMS requiring continuous monitoring during the 60-hour infusion and no home use, a potential problem for commercial marketing.
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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.
Janssen’s Esketamine: US FDA Panel To Weigh Efficacy, REMS Restrictions For Treatment-Resistant Depression
FDA proposes requiring that healthcare facilities monitor patients for sedation and dissociative effects for two hours after self-administration; reliance on a randomized withdrawal trial as one of two adequate, well-controlled studies to support approval would be a first in the depression setting.
After an advisory committee recommended approval for the postpartum depression treatment if administered under a REMS program at certified centers, Sage submitted a proposed REMS, causing the agency to extend the PDUFA date three months.