FDA Approves the First Postpartum Depression Drug
The FDA approved the first postpartum depression drug called Zulresso.
Zulresso is an IV injection used to treat the sometimes life-threatening condition of postpartum depression, which is a major depressive episode that occurs following or leading up to childbirth.
"Women may experience thoughts about harming themselves or harming their child. Postpartum depression can also interfere with the maternal-infant bond," said Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research.
Zulresso will only be available through a restricted program because of concerns about risks including excessive sedation or sudden loss of consciousness during administration. This requires the drug be administered by a health care provider in a certified health care facility.
Two clinical studies showed that Zulresso was superior to placebo and improved symptoms at the end of the first infusion.