Tuesday, November 14, 2017
Sage Therapeutics, a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, announced positive top-line results from two phase III 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 µg/kg/h dose and p=0.0011 for 60 µg/kg/h dose; Study 202C: p=0.0160 for 90 µg/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.