Zuranolone approved to treat postpartum depression

Care, woman feeding her baby with bottle and in living room on the sofa at their home. ©Felix/peopleimages.com. stock.adobe.com

On August 4, the FDA approved zuranolone (Zurzuvae), the first oral medication to treat postpartum depression (PPD) in adults.

Zuranolone, which had priority review and fast track designation, showed efficacy in 2 randomized, double-blind, placebo-controlled, multicenter studies. Participants were women with PPD who had met the DSM criteria for a major depressive episode and whose symptoms from a major depressive episode began in the third trimester or within 4 weeks of delivery. In the first study, patients received 50 mg of zuranolone or placebo once daily in the evening for 14 days. In the second study, patients received another zuranolone product that was equal to 40 mg of zuranolone or placebo, also for 14 days. All patients were monitored for at least 4 weeks after the 14-day treatment. Primary endpoint of both studies was a change in depressive symptoms using the total score from the 17-item Hamilton depression rating scale (HAMD-17). Patients in the zuranolone group showed greater improvement in their symptoms compared to the placebo group. Treatment was maintained at day 42, after the last dose of the medication.

The new drug has a boxed warning that zuranolone can impact a person's ability to drive and perform other activities, and, to reduce harm, those taking the medication should not drive or operate heavy machinery for at least 12 hours after taking. Common side effects include drowsiness, dizzinesss, diarrhea, fatigue, nasopharyngitis, and urinary tract infection. Use of the medication may cause fetal harm. Women should use effective contraceptive while taking, and for one week after taking, zuranolone.

Clinical data has shown that the pill works quickly, and can ease depression in as little as 3 days, much faster than other antidepressants.

Reference

FDA approvdes first oral treatment for postpartum depression. News release. FDA. August 4, 2023. Accessed August 5, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-postpartum-depression