FDA approves first oral treatment for postpartum depression


The Food and Drug Administration Friday approved a new hormone-based medication to treat postpartum depression, a condition that affects about 1 in 8 new mothers.

The medication, zuranolone, which will be sold under the brand name Zurzuvae, is the first FDA-approved oral treatment designed to address postpartum depression.

“PPD is a major depressive episode that typically occurs after childbirth but can also begin during the later stages of pregnancy. Until now, treatment for PPD was only available as an IV injection given by a health care provider in certain health care facilities,” the FDA said in a statement Friday.

The FDA gave the medication priority review and fast-track designation, which significantly quicken the approval process.

Unlike typical antidepressants, which take time to build up and take effect, zuranolone, is designed to work quickly and be taken for a short period of time, allowing new mothers to quickly treat postpartum depression.

“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 the director of the Division of Psychiatry at the FDA’s Center for Drug Evaluation and Research, Tiffany Farchione.

“Having access to an oral medication will be beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings,” Farchione continued.

The medication is based off allopregnanolone, which is a progesterone byproduct. When a woman is pregnant, their body produces a large amount of progesterone, which can crash after birth. The rapid decrease in progesterone levels is believed to contribute to postpartum depression.

The FDA says zuranolone should be taken at a recommended dose of 50mg in the evening with a fatty meal for 14 days.

Packaging for the medication will display warnings that it can interfere with a person’s ability to drive or perform risky tasks. Common side effects include diarrhea, dizziness, fatigue, drowsiness, urinary tract infections and the common cold.

More serious side effects include fetal harm and suicidal thoughts.

If you or someone you know is suicidal, call the National Suicide Prevention Lifeline at 988.


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