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Friday, August 31, 2018

Sage Therapeutics: The Lancet publishes data from pivotal trials of brexanolone


Sage Therapeutics announced The Lancet has published an integrated analysis across three, double-blind, randomized, placebo-controlled studies of brexanolone injection in women with postpartum depression. This new analysis, published for the first time, demonstrated significant and clinically meaningful reductions in HAM-D total score, a common measure of depression severity, following treatment with brexanolone 90 microg/kg/h at the primary timepoint of 60 hours compared with placebo. Statistically significant improvement in the HAM-D total score was first observed within 24 hours of initiating treatment and treatment response was durable through the 30-day follow-up. The most common adverse events during treatment across all studies were headache, dizziness and somnolence. The FDA has conditionally accepted the proprietary name ZULRESSO for Sage’s intravenous formulation of brexanolone.
https://thefly.com/landingPageNews.php?id=2784787

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