FDA approves first treatment for post-partum depression

The US Food and Drug Administration yesterday approved Zulresso (brexanolone) injection for the treatment of postpartum depression (PPD), with the news sending the shares of the drug’s developer, Sage Therapeutics (Nasdaq: SAGE) up more than 4% to $163 in post-market trading.

Zulresso is the first and only medicine specifically approved to treat PPD, the most common medical complication of childbirth. Zulresso is expected to be available in late June following scheduling by the US Drug Enforcement Administration, which is expected to occur within 90 days, Sage noted.

“Today’s approval of Zulresso represents a game-changing approach to treating PPD,” said Dr Samantha Meltzer Brody, M Hayworth Distinguished Professorship of Mood and Anxiety Disorders and director of the Perinatal Psychiatry Program, UNC Center for Women’s Mood Disorders and primary investigator of the Zulresso clinical trials. “The potential to rapidly reduce symptoms in this critical disorder is an exciting milestone in women’s mental health. PPD is recognized to have a significant and long-term impact on women and their families, but with Zulresso we may finally have the opportunity to change that.”