Positive pivotal trials for brexanolone in postpartum depression

US CNS specialist Sage Therapeutics (Nasdaq: SAGE) on Friday announced The Lancet has published an integrated analysis across three, double-blind, randomized, placebo-controlled studies of brexanolone injection in women with postpartum depression (PPD).

The paper, titled “ Brexanolone Injection in Post-Partum Depression: Two Multicentre, Double-blind, Randomised, Placebo-controlled Phase 3 Trials,” includes integrated results from three pivotal, placebo-controlled trials of brexanolone in women with a range of PPD severities.

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 µg/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.