The U.S. Food and Drug Administration (FDA) approved a milestone first pill treating postpartum depression (PPD), the agency wrote in a Friday press release.
Zurzuvae (zuranolone), a Sage Therapeutics product, is designed to address the “depressive episode that typically occurs after childbirth but can also begin during the later stages of pregnancy,” according to the FDA.
The pill will replace traditional IV injection treatment for PPD, the release continued.
“Postpartum depression is a serious and potentially life-threatening condition,” said Dr. Tiffany R. Farchione of the FDA.
PPD can cause women to “experience sadness, guilt, worthlessness — even, in severe cases, thoughts of harming themselves or their child,” Dr. Farchione continued before saying “it can also have consequences for the child’s physical and emotional development.”
According to FDA, Zurzuvae can impact a person’s ability to drive and perform other potentially hazardous activities — a warning included on the label of the medication #postpartumdepression https://t.co/9gbtGyjqUi
— IE Lifestyle (@lifestyle_ie) August 5, 2023
Zurzuvae was successfully tested with two 14-day studies involving women with PPD, the agency wrote in the release.
The pill has side effects and “can impact a person’s ability to drive and perform other potentially hazardous activities,” per the agency. It is to be taken in 50 mg daily doses for a period of 14 days, the release continued.
“Patients should not drive or operate heavy machinery for at least 12 hours after taking Zurzuvae,” according to the FDA. (RELATED: FDA Quietly Allows Pharma Firm To Profit Off Life-Saving Diabetes Treatment Right After GOP Proposal To Expand Access)
The price of the pill remains unknown. It could be prescribed to women who failed to respond when treated with antidepressants, Dr. Kimberly Yonkers of Yale University told The Associated Press.