• Posted August 5, 2023

FDA Gives Approval to Pill to Ease Postpartum Depression

The U.S. Food and Drug Administration on Friday approved a new pill, called 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, zuranolone (Zurzuvae) showed “rapid, significant and sustained” reductions in depressive symptoms when compared to 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's compared to the many weeks it typically takes for standard antidepressants to start taking full effect.

“Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness -- even, in severe cases, thoughts of harming themselves or their child. And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child's physical and emotional development,” Dr. Tiffany Farchione, director of the Division of Psychiatry in the FDA's Center for Drug Evaluation and Research, said in an agency statement. “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”

As many as 1 in 8 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," said Dr. Kristina Deligiannidis, lead author of the recent study. Many women also say they feel overwhelmed and are anxious, especially over the baby's well-being, she added.

Some women may start to believe that their family would be better off if they were dead, Deligiannidis added. She's a professor at the Institute of Behavioral Science at the Feinstein Institutes for Medical Research in Manhasset, N.Y.

Sahar McMahon, 39, of New York City, participated in the clinical trial of zuranolone after the birth of her second daughter. She never wanted to hurt herself, she told CNN, but she felt she "just was existing."

"There were points where my kids would be screaming. I would leave them screaming in the living room. I'd go in my room, close the door, scream into a pillow, and then I'd think, ‘What are we doing this for?'" McMahon said. “My whole thought process was very pessimistic, and that's not who I am at all."

After taking zuranolone, "I immediately just started feeling more like me,” she recalled.

Women like McMahon need more treatment options. “Standard of care antidepressants, while effective, take a few weeks to start to show benefit, with maximal benefit often not seen until after 8-12 weeks of treatment,” Deligiannidis said.

Moreover, these pills must be taken for months or years and can have chronic side effects.

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 healthcare setting.

"There have been barriers in getting this lifesaving medication to women, so the development of a related, oral option may increase treatment access," Deligiannidis noted.

Both brexanolone and zuranolone 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.

Zuranolone may also have a better safety profile than brexanolone, which has been associated with a loss of consciousness in some women.

There have been no reports of loss of consciousness with zuranolone use, Deligiannidis noted. The most common side effects with zuranolone were sleepiness, dizziness, sedation and headache.

Because of the danger of sedation, the FDA has put a black box warning on zuranolone's labeling, cautioning that users should not drive or operate heavy machinery within 12 hours of taking the pill.

“Since zuranolone is an acute, 14-day treatment course, the medication is not taken chronically, and side effects should be confined to the short-treatment course,” Deligiannidis said. The drug should be take in the evening along with "a fatty meal," the FDA noted.

The study, which was recently published in the American Journal of Psychiatry, was funded by zuranolone maker Sage Therapeutics and Biogen. According to the New York Times, the companies have not yet announced a price for the pill.

Women's health experts are excited about the possibility of a new option to treat postpartum depression.

“This could be a big deal,” said Dr. Misty Richards, an assistant clinical professor of child and adolescent psychiatry and obstetrics and gynecology at the University of California, Los Angeles.

Brexanolone can be prohibitively expensive, and requires an inpatient stay, which has been a barrier for many, Richards said.

“Zuranolone is taken by mouth, and we hope that will make it more affordable, and you see benefits as soon as three days,” she said.

Timing is of the essence when treating postpartum depression, Richards added.

“Symptoms can compromise the bonding of parents to the baby and the attachment of babies to the parent,” she explained.

Zuranolone's approval “will, to a great degree, have a very positive impact on the treatment of postpartum depression," agreed Dr. Nirmaljit Dhami, a psychiatrist at El Camino Health in Mountain View, Calif.

Postpartum depression symptoms can be chronic, and many women will experience relapses, she said.

“The hope is that this medication will lead to permanent remission of symptoms and that the patient will not need to take it on an ongoing basis," Dhami said.

Women experiencing symptoms of postpartum depression should not suffer in silence, she said.

“Let your support system know if you are having these feelings and symptoms,” Dhami said. “You are not alone and not at fault. This condition is treatable, so there is hope."

More information

Learn more about postpartum depression at the American College of Obstetricians and Gynecologists.

SOURCES: U.S. Food and Drug Administration, news release, Aug. 4, 2023; Kristina Deligiannidis, MD, professor, Institute of Behavioral Science, Feinstein Institutes for Medical Research, Manhasset N.Y.; Misty Richards, MD, assistant clinical professor, child and adolescent psychiatry, obstetrics and gynecology, University of California, Los Angeles; Nirmaljit Dhami, MD, psychiatrist, El Camino Health, Mountain View, Calif., American Journal of Psychiatry, July 26, 2023; CNN; New York Times