FDA Approves First Oral Treatment for Postpartum Depression

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On Aug. 4, 2023, FDA approved zuranolone (Zurzuvae), an oral medication to treat postpartum depression (PPD) in adults from Sage Therapeutics, a US-based biopharmaceutical company. According to an agency press release, zuranolone is the first oral treatment approved for PPD.

The approval was based on two studies that showed zuranolone’s effectiveness as a treatment for PPD. Patients who took zuranolone showed noticeably more improvement compared to those in the placebo groups, and the effect remained four weeks after the last dose of zuranolone.

PPD is a major depressive episode that usually occurs after childbirth, although it can also start in the later stages of pregnancy. As with other forms of depression, PPD can cause sadness, lethargy, and loss of interest in previously enjoyable activities. Symptoms include feelings of sadness or inadequacy, loss of energy, cognitive impairment, and suicidal ideation. Until this approval, PPD treatment was only available via intravenous injection given by a health care provider in a health care facility. FDA granted the application for Zurzuvae priority review and fast track designation.

“Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness—even, in severe cases, thoughts of harming themselves or their child. And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development,” said Tiffany R. Farchione, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, in FDA’s press release. “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”

Source: FDA