FDA on Tuesday approved a drug that specifically targets postpartum depression, marking the first time a drug has been approved for such a use in the United States—but some experts are concerned the drug's cost will restrict access to the treatment.
About postpartum depression
An estimated 400,000 U.S. women experience postpartum depression, which causes women to experience thoughts of suicide or feelings of worthlessness and guilt either during their pregnancies or within a month after childbirth, the Washington Post reports. Women with postpartum depression can become inattentive to their infants, which places their children at risk of a number of health problems, including developmental delays.
Postpartum depression currently is treated with antidepressants and psychotherapy, but current treatment options typically take four to eight weeks to fully take effect, and the effects are limited, according to the Post.
FDA approves new drug for postpartum depression
The treatment FDA approved Tuesday, Sage Therapeutics' Zulresso, is administered intravenously in one 60-hour session. The treatment takes effect within 48 hours, and one dose of the drug lasts for at least 30 days. The drug's primary component is allopregnanolone, which plays a role in mood regulation, according to the Post. FDA said three clinical trials that involved a total of 247 women with severe or moderate depression demonstrated the drug is more effective than a placebo.
Zulresso will only be available at certified health care facilities through FDA's restricted distribution program under a Risk Evaluation and Mitigation Strategy because patients who receive the treatment "must be monitored for excessive sedation," FDA said.
FDA mandated that the drug must include a boxed warning, which is the strongest warning FDA can require. The drug's label notes that there is evidence Zulresso transferred into new mothers' breast milk, but currently available data "do not suggest a significant risk of adverse reactions to breastfed infants from exposure to Zulresso."
According to the Post, Sage Therapeutics has said Zulresso will cost an average of $34,000 per patient for a course of treatment, which does not include any discounts the manufacturer could give for the drug. That estimated cost also does not include the price patients will pay to stay at a medical center for the drug's 60-hour administration period.
Experts praise the drug, but some express concerns about its cost
Jess Fiedorowicz, a psychiatrist at the University of Iowa and a member of an FDA advisory panel that recommended FDA approve the drug, called the drug "groundbreaking," noting that "[w]e don't have any treatments that are anywhere near this effective."
Margaret Spinelli, a clinical professor of psychiatry at Columbia University, said, "The major thing is, of course, the rapid effect. That it's the first that's designed for postpartum depression is important and means it will probably be a segue to design other medications for postpartum depression to be administered in an easier way."
Kimberly Yonkers—a professor of psychiatry, obstetrics, gynecology, and reproductive sciences at Yale University—said Zulresso might help up to 30% of the estimated 400,000 U.S. women who experience postpartum depression but do not respond to standard antidepressants or have severe symptoms. However, she said, "This brings up a lot of very complex public health issues," because the drug's cost and administration might hamper women's ability to access the treatment.
But Samantha Meltzer-Brody, a psychiatrist at the University of North Carolina at Chapel Hill who led clinical trials on the drug, said she does not expect the drug's intravenous administration will discourage women from using the treatment (McGinley/Bernstein, Washington Post, 3/19; Belluck, New York Times, 3/19; Shannon, USA Today, 3/19; Gilmour, Sacramento Bee, 3/19; FDA release, 3/19).
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