FDA approves first pill to treat postpartum depression

August 5, 2023

The U.S. Food and Drug Administration has approved the first pill specifically for the treatment of severe postpartum depression. 

“Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings,” Dr. Tiffany Farchione, the FDA’s director of psychiatric drugs, said in a statement Friday. 

The drug, called Zurzuvae, is to be taken once a day for two weeks and is meant for severe postpartum depression. Massachusetts-based Sage Therapeutics makes Zurzuvae.

Two studies conducted before the pill was approved showed fewer women had depression symptoms after taking it, including Sahar McMahon, 39, who said she signed up for the study after realizing she no longer wanted to spend time with her children.

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“I planned my pregnancies, I knew I wanted those kids, but I didn’t want to interact with them,” said McMahon told the Associated Press of her feelings after the birth of her second child in 2021. She said she had never previously suffered from depression.

“It was a quick transition for me just waking up and starting to feel like myself again,” she said, adding that she started to feel better after just days of using the pill, known chemically as zuranolone.

Zuranolone mimics a derivative of progesterone, the naturally occurring female hormone needed to maintain a pregnancy, which can plunge after childbirth.

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A similar drug from the same company, Sage Therapeutics, was approved in 2019, but has limited access because it cost $34,000 and was given intravenously at a clinic over three days. 

Sage hasn’t said what the pill will cost whose common side effects include drowsiness and dizziness. 

Depression after giving birth affects around 400,000 women each year and, although it sometimes goes away on its own, it can hang on for months or even years. 

Dr. Kimberly Yonkers of Yale University, a psychiatrist who specializes in postpartum depression and wasn’t involve in the tests, said Zurzuvae’s effect is “strong” and the drug likely will be prescribed for women who haven’t responded to antidepressants. 

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But she said FDA should have done more studies on how women would fare long-term. 

“It could be that people are well, or it could be that they relapse,” she noted. 

The Associated Press contributed to this report.

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