Zuranolone, branded as Zurzuvae, was approved by the U.S. Food and Drug Administration on Friday, making it the first oral medication meant to treat postpartum depression.

Pharmaceutical companies Sage Therapeutics Inc. and Biogen co-developed the drug, according to CNN.

Dr. Priya Singhal, executive vice president and head of development at Biogen, had earlier said in a news release, “We see potential for zuranolone, if approved, to be a meaningful new option that can help address the serious unmet need faced by the diverse populations struggling with” major depressive disorder and postpartum depression, per CNN.

“Because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development,” said Tiffany R. Farchione, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, in announcing FDA approval.

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

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What is 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,” Farchione said in the FDA’s news release.

It’s predicted that every year more than 400,000 U.S. babies are born to depressed mothers, according to CNN. Suicide accounts for about 20% of postpartum deaths.

The FDA recommends zuranolone be taken every evening for two weeks.

Since the most common side effects of the drug are drowsiness, dizziness and diarrhea, the FDA says those who take the drug should not drive or operate heavy machinery for a minimum of 12 hours after consumption.

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Study details

Approval for Zurzuvae was based on the results of two studies.

The FDA’s news release said all participants in the studies were women with postpartum depression who started exhibiting symptoms of a major depressive episode in the third trimester or within four weeks of delivery.

NPR said the studies lasted 45 days — one study had participants take Zurzuvae, the other had participants take a placebo — and showed that “women who took Zurzuvae had fewer signs of depression over a four- to six-week period when compared” to those who took a placebo.

Samantha Meltzer-Brody, director of the Center for Women’s Mood Disorders at the University of North Carolina at Chapel Hill, told The Washington Post that how quickly the medication takes action is significant since “other antidepressants can take weeks or even months to reach their full effect.”

Zurzuvae “is going to be a game changer for treating maternal depression,” Meltzer-Brody told the Post.

Others are more cautious. A psychiatrist who specializes in postpartum depression, Dr. Kimberly Yonkers of Yale University, told NPR the FDA should’ve required extended testing to see how women react to the pill in the long run.

“The problem is we don’t know what happens after 45 days,” Yonkers told NPR. “It could be that people are well or it could be that they relapse.”