Sage and Biogen Release Positive Phase 3 Data for Zuranolone

Sage Therapeutics and Biogen’s investigational drug zuranolone posted additional positive data from a phase 3 study evaluating the drug in adult women with postpartum depression.

Previously reported data showed that the study achieved statistically significant improvements in depressive symptoms at day 15 and achieved all primary and secondary endpoints. The new data showed that women in the 50 mg arm of the study achieved a decrease of 50 percent or better in the 17 symptoms of depression included in the Hamilton Rating Scale for Depression compared to those given a placebo.

The two companies have initiated a rolling submission of a New Drug Application (NDA) for the drug and plan to complete the NDA filing in the second half of this year.