Sage Therapeutics reported top-line results from the Phase 3 ROBIN study. This study evaluated the effect of SAGE-217 30 mg on depressive symptoms in women with postpartum depression . After two weeks of outpatient treatment, patients treated with SAGE-217 had a statistically significant improvement of 17.8 points in the Hamilton Rating Scale for Depression score, compared to 13.6 for placebo, with statistically significant reductions in HAMD-17 compared to placebo maintained through the end of the four-week follow-up. Remission was achieved in 45% of patients treated with SAGE-217 for two weeks as measured by the HAMD-17 compared with 23% of patients receiving placebo. Results from secondary endpoints were statistically significant and consistent with the primary endpoint. SAGE-217 was generally well-tolerated with a safety profile consistent with that seen in earlier SAGE-217 trials. Overall reports of AEs were similar between SAGE-217 (58%) and placebo (51%). Two subjects experienced serious adverse events, one subject in each group.
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