Sage Therapeutics reports 'positive' Phase 2 Brexanolone data
Sage Therapeutics announced that The Lancet has published results from a Phase 2, double-blind, randomized and placebo-controlled study of brexanolone in women with severe postpartum depression. The study found that treatment with brexanolone resulted in a clinically meaningful and statistically significant mean reduction in the 17-item Hamilton Rating Scale for Depression total score, a common measure of depression severity, that began at 24 hours and was maintained at similar magnitude until the 30-day follow-up. Brexanolone was well-tolerated in this study with no observations of deaths, serious adverse events or discontinuations. The study's primary efficacy endpoint was the mean change from baseline in the 17-item HAM-D total score in subjects who received brexanolone compared with subjects who received placebo at the 60-hour time point. As previously reported, at the end of the 60-hour infusion, brexanolone-treated subjects demonstrated a mean reduction in HAM-D total score of 20.97 points, a 12.2-point difference from placebo. The effect was statistically significant from 24 hours after initiation of treatment until the 30-day follow-up. No deaths, serious adverse events or discontinuations were observed. Overall, fewer patients who received brexanolone experienced adverse events compared with placebo. The most commonly reported adverse events in the trial were dizziness and somnolence and an equal number of patients reported the cluster of dizziness, sedation or somnolence.