FRIDAY, Dec. 15, 2023 (HealthDay News) — Zurzuvae (zuranolone), the first postpartum depression pill approved for use in the United States, is now available to women who need it. The medication, which is now stocked in specialty pharmacies, can also be shipped directly to patients, Biogen and Sage Therapeutics Inc. said in a news release Thursday.
“Having an option like Zurzuvae that can work at day 15 and improve symptoms in as early as three days has the potential to make a profound difference in the lives of women with PPD [postpartum depression],” Kristina Deligiannidis, M.D., a professor at the Feinstein Institutes for Medical Research in New York City who has been the lead investigator on the clinical trials that led to Zurzuvae’s approval, said in the company news release.
However, the treatment is not inexpensive: The medication will cost $15,900 per course before insurance.
Taken as a pill once a day for two weeks, Zurzuvae showed “rapid, significant, and sustained” reductions in depressive symptoms when compared to a placebo, according to a recent study of nearly 200 women, the FDA noted when it approved the medication back in August.
“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,” Tiffany Farchione, M.D., director of the Division of Psychiatry in the FDA Center for Drug Evaluation and Research, said in an agency news release announcing the approval. “And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development.”
The most common side effects with Zurzuvae were sleepiness, dizziness, sedation, and headache. Because of the danger of sedation, the FDA has put a black box warning on Zurzuvae’s labeling, cautioning that users should not drive or operate heavy machinery within 12 hours of taking the pill.
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