The Food and Drug Administration has approved the first drug designed to treat postpartum depression on Tuesday, and this could well be a life-changing development for many new mothers.
According to the New York Times, the drug is administered through IV and it works quickly, with patients feeling relief within 48 hours. This is definitely a significant improvement from the general antidepressant medications that are currently used to treat postpartum depression (PPD), which can take weeks to yield results.
Marketed as Zulresso, the new drug brexanolone requires the 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 the clinical trials.
It also comes with a hefty price tag, at $34,000 per infusion plus the cost of the two-day medical center stay. However, Zulresso’s manufacturer, Sage Therapeutics, expects the drug to be covered by insurance. The Times said that insurers are currently assessing the drug.
“Postpartum depression is a serious condition that, when severe, can be life-threatening," 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. "Women may experience thoughts about harming themselves or harming their child. Postpartum depression can also interfere with the maternal-infant bond."
She added, “This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option.”
According to the FDA, 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 while others were given a placebo, and then all were followed for another four weeks. In both studies, the women given Zulresso showed a marked improvement compared to those on the placebo.
Sage Therapeutics is also working on a pill form of the drug that appears to be working just as well, the Times reported. The company expects the pill to hit the market in the next couple of years.
According to the Centers for Disease Control (CDC), about one in ten women experiences postpartum depression in the United States. This number varies by state as in some areas of the country, it affects one in five women.