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.
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