The FDA approves the first pill specifically intended to treat postpartum depression
WASHINGTON — Federal health officials have approved the first pill specifically intended to treat severe depression after childbirth, a condition that affects thousands of new mothers in the U.S. each year.
The Food and Drug Administration on Friday granted approval of 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 coping with extreme, and sometimes life-threatening, feelings," said Dr. Tiffany Farchione, FDA's director of psychiatric drugs, in a statement.
Postpartum depression affects an estimated 400,000 people a year, and while it often ends on its own within a couple 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's given intravenously over three days in a medical facility. The FDA approved that drug in 2019, though it isn't widely used because of its $34,000 price tag and the logistics of administering it.
The FDA's pill approval is based on two company studies that showed women who took Zurzuvae had fewer signs of depression over a four- to six-week period when compared with those who received a dummy pill. The benefits, measured using a psychiatric test, appeared within three days for many patients.
Sahar McMahon, 39, had never experienced depression until after the birth of her second daughter in late 2021. She agreed to enroll in a study of the drug, known chemically as zuranolone, after realizing she no longer wanted to spend time with her children.
"I planned my pregnancies, I knew I wanted those kids but I didn't want to interact with them," said McMahon, who lives in New York City. She says her mood and outlook started improving within days of taking the first pills.
"It was a quick transition for me just waking up and starting to feel like myself again," she said.
Dr. Kimberly Yonkers of Yale University said the Zurzuvae effect is "strong" and the drug likely will be prescribed for women who haven't responded to antidepressants. She wasn't involved in testing the drug.
Still, she said, the FDA should have required Sage to submit more follow-up data on how 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 could be that people are well or it could be that they relapse."
Sage did not immediately announce how it would price the pill, and Yonkers said that'll be a key factor in how widely its prescribed.
Side effects with the new drug are milder than the IV version, and include drowsiness and dizziness. The drug was co-developed with fellow Massachusetts pharmaceutical company Biogen.
Both the pill and IV forms mimic a derivative of progesterone, the naturally occurring female hormone needed to maintain a pregnancy. Levels of the hormone can plunge after childbirth.
Sage's drugs are part of an emerging class of medications dubbed neurosteroids. These stimulate a different brain pathway than older antidepressants that target serotonin, the chemical linked to mood and emotions.