Sage Therapeutics Says Brexanolone Injection Shows ‘Meaningful’ Reduction in Depression Severity Among Women

Sage Therapeutics (SAGE) said late Friday an analysis across three studies of brexanolone injection in women with postpartum depression (PPD) demonstrated “significant and clinically meaningful” reductions in HAM-D total score, a common measure of depression severity. Shares climbed slightly higher intraday.

The double-blind, randomized, and placebo-controlled studies showed the reductions following treatment with brexanolone 90 µg/kg/h at the primary timepoint of 60 hours compared with placebo, according to a statement.

The firm said a 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 headaches, dizziness, and somnolence.

The Food and Drug Administration has conditionally accepted the proprietary name Zulresso for Sage’s intravenous formulation of brexanolone, the statement said, while noting that PPD is estimated to affect about 10%-20% of women giving birth globally.