FDA Gives Approval to Pill to Ease Postpartum Depression

MONDAY, Aug. 7, 2023 (HealthDay News) -- The U.S. Food and Drug Administration on Friday approved a new pill, called Zurzuvae (zuranolone), that may quickly ease severe postpartum depression and help millions of women regain their emotional equilibrium following childbirth.

Taken as a pill once a day for two weeks, Zurzuvae showed "rapid, significant and sustained" reductions in depressive symptoms when compared with a placebo, according to a recent study of nearly 200 women, the FDA said. These improvements occurred in as few as three days and were still evident 28 and 45 days later. That is compared with the many weeks it typically takes for standard antidepressants to start taking full effect.

As many as one in eight women in the United States develops depression just before or after giving birth.

"Women report severe sadness or loss of interest in pleasurable activities and relationships, have significant guilt, often about not being a good enough mother or partner, low energy, poor concentration and indecisiveness, loss of appetite, and irritability," Kristina Deligiannidis, M.D., lead author of the recent study published in The American Journal of Psychiatry, told HealthDay.

The FDA approval of Zulresso (brexanolone) in 2019 for postpartum depression was a breakthrough, but the drug is delivered via a 60-hour intravenous infusion in a health care setting. Both Zulresso and Zurzuvae are versions of allopregnanolone, a neuro-active steroid that is a byproduct of the hormone progesterone. Levels of allopregnanolone can rise dramatically during pregnancy and then crash after childbirth, potentially contributing to postpartum depression.

"Although it is not yet known exactly how zuranolone has rapid antidepressant effects, research suggests that neuro-steroids like zuranolone work to support brain health by rapidly reducing stress and restoring healthy brain network connections," Deligiannidis explained.

Zurzuvae may also have a better safety profile than Zulresso, which has been associated with a loss of consciousness in some women. There have been no reports of loss of consciousness with Zurzuvae use, Deligiannidis noted. 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 the Zurzuvae labeling, cautioning that users should not drive or operate heavy machinery within 12 hours of taking the pill.

Approval of Zurzuvae was granted to Sage Therapeutics.

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