Monday, August 7, 2023

FDA Approves First Oral Medication for Postpartum Depression

The U.S. Food and Drug Administration (FDA) on Friday approved Zurzuvae (zuranolone), the first oral medication for the treatment of postpartum depression in adults. Zuranolone acts on similar receptors in the brain as the intravenous medication brexanolone, which was the first postpartum depression medication to receive FDA approval in 2019.

“As a perinatal psychiatrist, I see the devastating impact [postpartum depression] has on mothers, particularly on the important mother-infant bond and long-term child development,” Kristina Deligiannidis, M.D., principal investigator of the Zurzuvae clinical program, said in a press release issued by Sage Therapeutics. Zuranolone and brexanolone are both manufactured by Sage Therapeutics.

“[W]ith Zurzuvae, we now have an oral treatment option that can provide rapid improvements in depressive symptoms in as early as three days for women with [postpartum depression],” continued Deligiannidis, who is also a professor at the Institute of Behavioral Science at the Feinstein Institutes for Medical Research in Manhasset, N.Y., and director of Women’s Behavioral Health at Zucker Hillside Hospital.

The efficacy of Zurzuvae was demonstrated in two randomized, double-blind, placebo-controlled trials—one of which was reported July 26 in The American Journal of Psychiatry. As described in the AJP report, 196 women aged 18 to 45 with severe postpartum depression were assigned to take either zuranolone (50 mg) or placebo pills daily for 14 days. Those in the zuranolone group experienced significantly greater improvements in their depressive symptoms than those taking placebo pills, and the improvements were maintained one month after the last zuranolone dose. Similar outcomes were reported in the other trial, where women with postpartum depression also received another formulation of zuranaolone (equivalent to 40 mg of Zurzuvae) or placebo for 14 days.

The recommended dose for Zurzuvae is 50 mg daily for 14 days. The medication is to be taken in the evening with a fat-containing food.

“This approval could be a game changer for psychiatry,” Jennifer Payne, M.D., vice-chair for research and a professor of psychiatry and neurobehavioral science at the University of Virginia School of Medicine, told Psychiatric News. Payne, who is an expert in women’s mood disorders, has consulted for Sage in the past but was not involved in the clinical development of zuranolone. “Not only does zuranolone continue the field’s paradigm shift toward rapid-acting depression treatment, but patients only need to take this medication for two weeks and not the rest of their lives.”

Sage predicted in the company press release that Zurzuvae will be available later this year, following the scheduling of the medication as a controlled substance by the U.S. Drug Enforcement Administration.

To read more on this topic, see the Psychiatric News article “Oral Medication Shows Promise for Postpartum Depression” and The American Journal of Psychiatry article “Zuranolone for the Treatment of Postpartum Depression.”

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