Health regulators in the United States have approved the first pill to treat postpartum depression, offering a lifeline to the as many as one in seven new mothers who suffer from the condition each year.
The US Food and Drug Administration (FDA) said on Friday it had approved Zurzuvae, manufactured by Biogen and Sage Therapeutics, for treating severe depression related to childbirth or pregnancy.
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Until now, treatment for postpartum depression in the US was only available in the form of an intravenous injection.
The drug, Brexanolone, requires a 60-hour intravenous infusion in a hospital and costs about $34,000, according to the New York Times.
Sage Therapeutics and Biogen, which is headquartered in Cambridge, Massachusetts, said it expected the drug to be commercially available this year.
“Zurzuvae is expected to launch and be commercially available in the fourth quarter of 2023 shortly following scheduling as a controlled substance by the US Drug Enforcement Administration, which is anticipated to occur within 90 days,” Sage Therapeutics and Biogen said in a statement.
The FDA approval comes after two company studies found that women who took the drugs had fewer signs of depression over a four-to-six-week period, with the benefits for many patients noticeable within three days. Zurzuvae’s reported side effects include drowsiness and dizziness.
The price of the pill, which is taken once a day for 14 days, has yet to be announced by its manufacturer.