FDA decision on first postpartum depression drug expected today

The FDA is expected to announce today whether it will approve the first drug specifically targeted to treat postpartum depression. The condition, which is the most common complication of childbirth, affects roughly 400,000 women in the U.S. every year, only about half of whom are diagnosed and treated because of the stigma around reporting symptoms. If approved, brexanolone would be the first drug developed by Sage Therapeutics to hit the market. Across three clinical trials that enrolled more than 200 women with postpartum depression, brexanolone demonstrated significant and meaningful reductions in depressive symptoms compared to a placebo.