First Oral Medication for Treating Postpartum Depression Approved by the FDA

On August 4, the US Food and Drug Administration (FDA) approved Zurzuvae (zuranolone), the first oral medication indicated for the treatment of postpartum depression (PPD) in adults.

PPD is a major depressive episode that typically presents following childbirth but can also occur during late pregnancy. Similar to other forms of depression, PPD is characterized by sadness and/or the loss of interest in everyday activities and decreased ability to feel pleasure. It can be accompanied by symptoms such as cognitive impairment, feelings of sadness or inadequacy, loss of energy, and suicidal ideation.

Researchers assessed Zurzuvae in 2 randomized, double-blind, placebo-controlled, multicenter studies. The subjects in both studies were women with PPD who met the Diagnostic and Statistical Manual of Mental Disorders criteria for a major depressive episode and whose symptoms manifested in the third trimester or within 4 weeks of delivery. In the first study, patients were administered Zurzuvae 50 mg or placebo once daily in the evening for 14 days. In the second study, patients received another zuranolone product that was “approximately equal” to Zurzuvae 40 mg or placebo, also for 14 days. The primary outcome of both studies was defined as change in depressive symptoms using the total score from the 17-item Hamilton Depression Rating Scale, measured at day 15.

According to the results, patients in both Zurzuvae groups demonstrated significantly more improvement in their symptoms compared with those in the placebo groups. Moreover, long-term treatment efficacy was robust; the effect remained at day 42, 4 weeks after the last dose of Zurzuvae.

“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 a 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.”