The US FDA approved zuranolone 50 mg as the first oral, once-daily treatment for postpartum depression in adults.
The US Food and Drug Administration (FDA) approved zuranolone 50 mg (Zurzuvae™, Sage Therapeutics, Inc) as the first oral, once-daily treatment for postpartum depression (PPD) in adults, according to an agency press release.1
Prior to this approval, treatment for PPD was only available through IV infusion given by health care providers over 2 days in certified facilities, noted the FDA’s August 4, 2023, statement.1
“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, MD, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, in the release.1
“Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings,” continued Farchione.
The approval is based on the efficacy of zuranolone for PPD demonstrated in the NEST clinical development program. The program included 2 randomized, double-blind, placebo-controlled, multicenter studies that included women with PPD who met the Diagnostic and Statistical Manual of Mental Disorders criteria for a major depressive episode and whose symptoms started in the third trimester or within 4 weeks of delivery.1
In the first study, participants received zuranolone 50 mg or placebo once daily at night for 14 days. In the second study, women were given another zuranolone product that was approximately equal to 40 mg of zuranolone or placebo for 14 days. Participants in both studies were followed for at least 4 weeks after the 14-day treatment. The primary endpoint of both studies was the change in depressive symptoms using the total score from the 17-item Hamilton depression rating scale (HAMD-17), measured at day 15, according to the FDA.1
“Patients in the Zurzuvae groups showed significantly more improvement in their symptoms compared to those in the placebo groups. The treatment effect was maintained at day 42—four weeks after the last dose of Zurzuvae,” wrote the agency.1
The FDA is requiring zuranolone to include a black box label warning that use of the medication could impair a patient’s ability to drive or conduct potentially hazardous activities and that impairment may not be easy to assess. “To reduce the risk of harm, patients should not drive or operate heavy machinery for at least 12 hours after taking Zurzuvae,” stated the FDA.1
The most common adverse effects associated with use of zuranolone were drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection. In addition, zuranolone use might cause suicidal thoughts and behavior and might affect a fetus. Patients should use effective contraception while taking zuranolone and for 1 week after use, according to the release.1
“Today marks a groundbreaking day for the treatment of PPD, as with ZURZUVAE we now have an oral treatment option that can provide rapid improvements in depressive symptoms in as early as three days for women with PPD,” said Kristina Deligiannidis, MD, principal investigator in the NEST program, and associate professor at the Feinstein Institutes for Medical Research in Manhasset, New York, in the manufacturer’s press release. “As a perinatal psychiatrist, I see the devastating impact PPD has on mothers particularly on the important mother-infant bond and long-term child development. Once available, I believe ZURZUVAE will be a meaningful option for patients in need.”2
1. FDA Approves First Oral Treatment for Postpartum Depression. US Food and Drug Administration. News release. Published August 4, 2023. Accessed August 7, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-postpartum-depression
2. FDA Approves ZURZUVAE™ (zuranolone), the First and Only Oral Treatment Approved for Women with Postpartum Depression, and Issues a Complete Response Letter for Major Depressive Disorder. Sage Therapeutics. News release. Published August 4, 2023. Accessed August 7, 2023. https://investor.sagerx.com/news-releases/news-release-details/fda-approves-zurzuvaetm-zuranolone-first-and-only-oral-treatment