WASHINGTON (NEWSnet/AP) — Federal health officials have approved the first pill specifically intended to treat severe depression after childbirth, a condition that affects thousands of mothers in the U.S. each year.

Food and Drug Administration on Friday granted approval of the drug, for adults experiencing severe depression related to childbirth or pregnancy. The pill is taken once per day for 14 days.

Postpartum depression affects an estimated 400,000 people each year. Although it usually subsides within a few 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. FDA approved that drug in 2019, although it isn’t widely used because of its $34,000 cost and logistic challenge of administering it.

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 placebo. The benefits, measured using a psychiatric test, appeared within three days for many patients.

Dr. Kimberly Yonkers of Yale University said the Zurzuvae effect is “strong” and the drug will be prescribed for women who haven’t responded to antidepressants. She wasn't involved in testing the drug.

Yonkers said FDA should have required Sage to submit more follow-up data regarding how women fared after additional months.

Sage did not announce price of the pil. 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.

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