Sage and Biogen build out case for depression drug as it passes PhIII test in postpartum women

Sage Therapeutics and Biogen are continuing a march forward in the depression space and have new data that they hope will wow investors and the FDA alike.

A Phase III study of zuranolone met all its primary and key secondary endpoints for treating women with postpartum depression (PPD). The drug is also being developed to treat major depressive disorder (MDD).

According to the data, women treated with a 50 mg dose of zuranolone demonstrated a statistically significant and clinically meaningful improvement in depressive symptoms after two weeks, meeting the primary endpoint. Researchers compared the changes in baseline to placebo as measured by the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score.

The average HAMD-17 total score at Day 15 for women who received zuranolone was -15.6 (0.82) compared with -11.6 (0.82) for women who received placebo, reaching a difference of -4.0 points. That clocked in at a p-value of…
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