Shares of Sage Therapeutics jumped more than 5 percent after hours Tuesday based on news that 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.
Sage’s stock was up more than 60 percent year to date in anticipation of the approval.
