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Sage's Postpartum Depression Drug Brexanolone Faces Loss-Of-Consciousness Questions

 
• By Derrick Gingery

US FDA is recommending a REMS requiring continuous monitoring during the 60-hour infusion and no home use, a potential problem for commercial marketing.

MR image of Human brain

SAGE Therapeutics Inc.'s postpartum depression drug brexanolone may see its patient population limited by US FDA requirements for continuous monitoring and lack of home use.

If approved, brexanolone, which is purported to be a positive allosteric modulator of GABAA receptors, would be the first

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