US FDA approves first postpartum depression pill

WASHINGTON — Federal health officials have approved the first pill specifically designed to treat severe depression after childbirth, a condition that affects thousands of new mothers in the United States each year.

The Food and Drug Administration on Friday approved the drug Zurzuvae for adults experiencing severe depression related to childbirth or pregnancy. The pill is taken once a day for 14 days.

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

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Postpartum depression affects about 400,000 people a year, and while it often ends on its own within a couple of weeks, it can continue for months or even years. Standard treatment includes counseling or antidepressants, which can take weeks to work and don’t help everyone.

The new pill is from Sage Therapeutics, which has a similar infused drug that is administered intravenously over three days at a medical facility. The FDA approved that drug in 2019, though it’s not widely used due to its $34,000 price tag and the logistics of administering it.

The FDA’s approval of the pill is based on two company studies that showed women who took Zurzuvae had fewer signs of depression over a period of four to six weeks compared to those who received a dummy pill. The benefits, measured by a psychiatric test, appeared within three days for many patients.

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Sahar McMahon, 39, had never experienced depression until after the birth of her second daughter in late 2021. She agreed to sign up for a study of the drug, known chemically as zuranolone, after realizing she no longer wanted to spend time with your children.

“I planned my pregnancies, I knew I wanted these kids but I didn’t want to interact with them,” said McMahon, who lives in New York City. She says that her mood and her outlook began to improve within a few days of taking the first pills.

“It was a quick transition for me to just wake up and start feeling like myself again,” she said.

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Dr Kimberly Yonkers of Yale University said the Zurzuvae effect is “strong” and the drug is likely to be prescribed to women who have not responded to antidepressants. She did not participate in the drug test.

Still, he said, the FDA should have required Sage to submit more follow-up data on how the women fared after additional months.

“The problem is we don’t know what happens after 45 days,” said Yonkers, a psychiatrist who specializes in postpartum depression. “It may be that people are fine or it may be that they relapse.”

Sage did not immediately announce what the price of the pill would be, and Yonkers said that will be a key factor in the breadth of its prescription.

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Side effects of the new drug are milder than those of the IV version and include drowsiness and dizziness. The drug was co-developed with Massachusetts pharmaceutical company Biogen.

Both the pill and intravenous forms mimic a derivative of progesterone, the natural female hormone needed to maintain a pregnancy. Hormone levels can drop after delivery.

Sage drugs are part of an emerging class of drugs called neurosteroids. These stimulate a different brain pathway than older antidepressants that target serotonin, the chemical linked to mood and emotions.

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