FDA Okays Sage Therapeutics' Zulresso Injection To Treat Postpartum Depression

(RTTNews) - Sage Therapeutics (SAGE) announced the U.S. Food and Drug Administration has approved Zulresso or brexanolone injection for the treatment of postpartum depression or PPD. 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 U.S. Drug Enforcement Administration, which is expected to occur within 90 days.

PPD can affect women during pregnancy or after childbirth. It is estimated PPD affects approximately one in nine women who have given birth in the U.S. Symptoms may include sadness, anxiety, irritability, withdrawing from friends or family, having trouble bonding with her baby and thinking about harming herself or more rarely, her baby. Without proper screening, up to half of PPD cases may go undiagnosed.

The FDA approval of ZULRESSO is based on findings from three multicenter, randomized, double-blind, parallel-group, placebo-controlled trials, designed to evaluate the safety and effectiveness of ZULRESSO in women with moderate and severe PPD, aged between 18 and 45 years who were =6 months postpartum at screening and who had onset of symptoms no earlier than the third trimester and no later than the first four weeks following delivery.