Breakthrough Approval: FDA Greenlights Powerful Pill Zurzuvae to Combat Postpartum Depression

The U.S. Food and Drug Administration (FDA) has approved the oral pill Zurzuvae, developed by Biogen and Sage Therapeutics, to treat postpartum depression (PPD) in adults.

The companies sought FDA approval for Zurzuvae to treat major depressive disorder (MDD) and postpartum depression, both of which impact millions of people.

Postpartum depression severely affects a woman's ability to function normally and may impact the mother's relationship with her child.

Zurzuvae is expected to be commercially available in the fourth quarter of 2023, following scheduling as a controlled substance by the U.S. Drug Enforcement Administration.

The FDA issued a Complete Response Letter for Zurzuvae's New Drug Application for the treatment of adults with MDD, stating the application lacked substantial evidence of its effectiveness in treating MDD, requiring further studies for approval.

Sage Therapeutics and Biogen are reviewing the FDA's feedback and evaluating their next steps.

Analysts anticipated potential stock drops for both companies if the drug was approved solely for postpartum depression, as the patient population for PPD is smaller.

Prior to Zurzuvae's approval, treatment for postpartum depression was only available as an intravenous injection.

In 2021, approximately 21 million adults in the United States experienced at least one episode of major depressive disorder.

Postpartum depression affects about one in seven women who give birth.