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Tuesday, June 13, 2017

SAGE Therapeutics (SAGE) reports Phase 2 Brexanolone clinical data



SAGE Therapeutics reports Phase 2 Brexanolone (SAGE-547) clinical data published in The Lancet:
Co announced that The Lancet has published results from a Phase 2, double-blind, randomized and placebo-controlled study of brexanolone (SAGE-547) 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.
  • Overall, fewer patients who received brexanolone experienced adverse events compared with placebo (4 of 10 on brexanolone and 8 of 11 on placebo).

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