Health regulators in the United States have granted approval for the first pill to treat postpartum depression, providing hope to the estimated one in seven new mothers who experience this condition each year.
The US Food and Drug Administration (FDA) announced the approval of Zurzuvae, developed by Biogen and Sage Therapeutics, as a treatment for severe depression related to childbirth or pregnancy.
Until now, postpartum depression treatment in the US was only available through intravenous injection.
The previously approved drug, Brexanolone, required a 60-hour intravenous infusion in a hospital and cost approximately $34,000, as reported by the New York Times.
Sage Therapeutics and Biogen, headquartered in Cambridge, Massachusetts, anticipate that Zurzuvae will be commercially available later 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,” stated Sage Therapeutics and Biogen in a joint statement.
The FDA’s approval came after two company studies showed that women who took the drug experienced reduced signs of depression over a four-to-six-week period, with noticeable benefits for many patients within three days. Reported side effects of Zurzuvae include drowsiness and dizziness.
The price of the pill, which is taken once a day for 14 days, is yet to be announced by the manufacturers.
