=SAGE Therapeutics (SAGE): positive top-line results from two Phase 3 clinical trials

SAGE Therapeutics announces positive top-line results from two Phase 3 clinical trials with its proprietary i.v. formulation of brexanolone (USAN; formerly SAGE-547); Study 202B in severe postpartum depression (PPD) and Study 202C in moderate PPD

Brexanolone achieved the primary endpoint in both trials, a mean reduction from baseline in the Hamilton Rating Scale for Depression (HAM-D) total score compared to placebo at 60 hours (Study 202B: p=0.0242 for 90 g/kg/h dose and p=0.0011 for 60 g/kg/h dose; Study 202C: p=0.0160 for 90 g/kg/h dose). Patients treated with brexanolone demonstrated mean reductions from baseline in HAM-D total scores of 14 to 20 points at 60 hours maintained to 30 days in both trials. Brexanolone was generally well tolerated and showed a similar safety profile as seen in earlier studies.

• Sage plans to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in 2018.