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FDA approves the first oral medication to treat postpartum depression

The FDA recently approved the use of Zurzuvae, an oral medication that can help treat postpartum depression. Photo: Liza Summer/Pexels Website.

Hope for Maternal Mental Health

By Mary Beth Sallee

Jobe Publishing, Inc.


Postpartum depression (PPD) is a major depressive illness that can affect mothers after childbirth and even during pregnancy. It is a serious and life-threatening condition that can affect not only the mother’s physical and emotional health, but the child’s as well.

Previously, PPD treatment was only available as an IV injection that had to be administered within a healthcare facility and under the supervision of a healthcare provider.

However, new hope has emerged as a new medication is now approved.

On August 4, the United States Food and Drug Administration (FDA) approved Zurzuvae (zuranolone) as the first oral medication to treat PPD.

The FDA website stated that two studies were held to test the effectiveness of Zurzuvae for the treatment of PPD.

“The trial participants were women with PPD who met the Diagnostic and Statistical Manual of Mental Disorders criteria for a major depressive episode and whose symptoms began in the third trimester or within four weeks of delivery,” the FDA website stated. “In Study 1, patients received 50 mg of Zurzuvae or placebo once daily in the evening for 14 days. In Study 2, patients received another zuranolone product that was approximately equal to 40 mg of Zurzuvae or placebo, also for 14 days. Patients in both studies were monitored for at least four 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,” the website continued. “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.”

According to the FDA, the most common side effects of Zurzuvae include dizziness, drowsiness, fatigue, diarrhea, urinary tract infection, and nasopharyngitis (also known as the common cold). Zurzuvae may also cause suicidal behaviors and thoughts and also fetal harm. The medication can also impact a person’s ability to drive.


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