FDA Approves First Drug to Treat Postpartum Depression
The drug, administered by IV, is said to provide almost immediate relief
In what could be a life-changing development for new mothers, the Food and Drug Administration approved the first drug designed to treat postpartum depression on Tuesday.
The drug, administered through an IV, is said to work swiftly, with patients feeling relief within 48 hours, according to the New York Times. It’s a major improvement from the general antidepressant medications that doctors currently use for postpartum depression (PPD) treatment, which can take weeks to work, if they do at all.
Marketed as Zulresso, the new drug brexanolone requires a patient to spend significant time in a certified medical center. The drug’s infusion takes 60 hours and necessitates supervision in case of dizziness or fainting, which some patients experienced during clinical trials.
It’s also pricey, coming in at $34,000 per infusion — and costs even more after factoring in the two-day medical center stay. But Zulresso’s manufacturer, Sage Therapeutics, expects the drug to be covered under insurance. The Times said that insurers are currently assessing the drug.
“Postpartum depression is a serious condition that, when severe, can be life-threatening. Women may experience thoughts about harming themselves or harming their child. Postpartum depression can also interfere with the maternal-infant bond,” Dr. Tiffany Farchione, the acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option.”
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Researchers evaluated the drug in two clinical studies — one with women with severe PPD, and the other on women with moderate PPD. In both studies, some women received the 60-hour infusion and others were given a placebo, and then all were followed for another four weeks. And in both studies, the women given Zulresso showed a marked improvement compared to those on the placebo, the FDA said.
Sage Therapeutics is also working on a pill form of the drug that appears to be working just as well, the Times reported, and the company expects to have it ready in the next couple of years.