FDA approves the use of Zurzuvae pill to treat postpartum depression in adults

The United States Food and Drug Administration (FDA) has granted approval for the use of the Zurzuvae (zuranolone) pill in the treatment of postpartum depression (PPD) in adults. According to the FDA statement, the pill is recommended to be taken once daily for 14 days during the evening with a fatty meal, with a daily dosage of 40 milligrams. The approval was given to Sage Therapeutics, Inc.

Dr Tiffany Farchione, FDA’s director of psychiatric drugs, highlighted the severity of postpartum depression, stating that it is a serious and potentially life-threatening condition that can lead to feelings of sadness, guilt, and worthlessness, and in severe cases, even thoughts of self-harm or harm to the child. The condition can also have consequences for the maternal-infant bond and the child’s emotional and physical development.

The effectiveness of Zurzuvae in treating PPD in adults was demonstrated in two studies involving women who met the criteria for a major depressive episode in the Diagnostic and Statistical Manual of Mental Disorders and whose symptoms began in the third trimester or within four weeks of delivery. In both studies, patients were administered Zurzuvae or placebo for 14 days and were monitored for at least four weeks after the treatment. The primary endpoint was the change in depressive symptoms measured by the Hamilton depression rating scale (HAMD-17) total score on day 15, and patients in the Zurzuvae groups showed significant improvement in their symptoms compared to those in the placebo groups. The treatment effect was sustained even four weeks after the last dose of Zurzuvae.

While Zurzuvae has been found effective, it also comes with some side effects, including drowsiness, dizziness, diarrhea, fatigue, and common cold. Additionally, the use of the drug may lead to suicidal thoughts and behavior, and it is also important to note that Zurzuvae can cause fetal harm. Women taking the drug are advised to use effective contraception while on the medication and for one week after stopping the treatment.