Shares of Sage Therapeutics (NASDAQ:SAGE) reached skyward early Wednesday based on news that the Food and Drug Administration 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.
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.
Zulresso was evaluated by the FDA under Priority Review, which is reserved for investigational therapies that, if approved, may offer significant improvements in the treatment, prevention or diagnosis of a serious condition.
In 2016, Zulresso was also granted Breakthrough Therapy Designation status, underscoring the significant unmet need in women with PPD.
CEO Jeff Jonas says, "We are grateful for the patients, researchers, healthcare providers, advocates, caregivers and Sage employees who helped secure the approval of the first medicine specifically for postpartum depression.
"Not only do we believe Zulresso will address an important need for women’s mental health, the impact of PPD is multi-generational, and we look forward to bringing Zulresso to patients in urgent need of a new treatment option.”
Shares zoomed $5.74, or 3.7%, to $161.84 early Wednesday.
