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The First Pill for Postpartum Depression Is Almost Here

About one in eight women in the United States experiences postpartum depression after giving birth. Soon, there may finally be a convenient, fast-acting medication to treat it—if the Food and Drug Administration gives it the green light.

The pill, called zuranolone, is taken over the course of 14 days and works to relieve depressive symptoms in as soon as three days. The FDA is expected to decide whether to approve the drug by August 5. If they do, it would be the first pill specifically designed to treat postpartum depression. (Update: On August 4, the FDA approved the drug, which will be sold under the brand name  Zurzuvae.) 

“This will be a game changer,” says Jennifer Payne, director of the Reproductive Psychiatry Research Program at the University of Virginia School of Medicine, who treats patients with postpartum depression and researches the biological mechanisms behind it.

While many people experience short-term mood swings after childbirth—often called the “baby blues''—postpartum depression lasts longer and is more severe, affecting a person’s ability to function normally. Symptoms include extreme feelings of sadness, anxiety, panic, and fatigue. Those with postpartum depression may also feel disconnected from their babies and have trouble bonding.

During pregnancy, the hormones estrogen and progesterone increase about 10-fold. A few days after delivery, they plummet to pre-pregnancy levels. This sudden drop is thought to be a major contributing factor to postpartum depression.

Considered a neurosteroid, zuranolone is a synthetic version of allopregnanolone, a naturally occurring byproduct of progesterone. It acts on GABA receptors in the brain—a major signaling pathway that helps regulate stress and mood. GABA calms the nervous system down, and people with major depression and chronic stress have been found to have lower levels of this chemical.

Essentially, zuranolone works by “resetting the neural circuits back to normal functioning, so that the brain can handle stress as it should,” says Kristina Deligiannidis, a psychiatrist at the Feinstein Institutes for Medical Research in New York who led a clinical trial of the medication.

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The study, published last week in The American Journal of Psychiatry, followed 196 women with postpartum depression for 45 days. Half were randomized to receive zuranolone, while the other half got a placebo. After two weeks, 57 percent of those who took zuranolone experienced significant improvement in their depressive symptoms compared to 38 percent who got a placebo. By the end of the trial, nearly 62 percent of those who received zuranolone were still experiencing significant relief, compared to 54 percent of the placebo group.

Side effects included drowsiness, dizziness, headache, diarrhea, and nausea. The trial was funded by Massachusetts biotech companies Sage Therapeutics and Biogen. (The drug is also being considered by the FDA to treat major depressive disorder more generally.) [Update: The FDA denied approval for this indication on August 4.]

Zuranolone wouldn’t be the first drug approved specifically for postpartum depression, although it would be the first pill. In 2019, the FDA approved brexanolone, sold under the brand name Zulresso. Also manufactured by Sage Therapeutics, the drug costs $34,000. But it isn’t widely used, partly because it is given as an IV infusion over two and a half days, meaning patients must stay in the hospital. There’s also a risk that users can suddenly lose consciousness as it’s being administered, so it’s only available at certain qualified health care facilities. (Notably, no participants in trials of zuranolone have experienced loss of consciousness, which is crucial, since the ideal treatment would be one that could be taken at home.)

Zobeida Diaz, a perinatal psychiatrist at Women and Infants Hospital in Rhode Island, says the hospital has administered Zulresso to around 60 patients since it was approved and has seen very positive results. “But the problem is that having to admit someone for an IV infusion in the hospital creates a barrier for most women to get this treatment,” she says, adding that a pill would open up access to many more patients.

Compared to current antidepressants, zuranolone is also fast-acting. A class of antidepressants called selective serotonin reuptake inhibitors, or SSRIs, can be effective at treating postpartum depression, but they may take weeks or months to have an effect. These drugs work by increasing levels of the neurotransmitter serotonin in the brain. Many patients taking traditional antidepressants do so for several years, and some might not benefit from the first drug they’re prescribed, so they may have to try others until they find one that works. “That can really delay appropriate treatment for these women,” Diaz says.

By contrast, zuranolone can begin relieving symptoms after just two doses. “One of the selling points of this compound is its rapid onset of action,” says Kimberly Yonkers, a professor and the chair of psychiatry at UMass Medical School and UMass Memorial Medical Center. “But we do not know how enduring the effect is.” Postpartum depression can last months—even a few years—after childbirth, and it’s unknown whether symptoms will come back after a two-week course of the drug.

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And the pill will only be able to help people who get a diagnosis and prescription in the first place. Postpartum depression symptoms aren’t always easily recognized by new parents, family members, and doctors. There’s no test to predict who will develop it, but research by Payne has found that the risk is highest among first-time mothers, those younger than 25, and mothers of twins. Low-income mothers and women of color are also at higher risk of postpartum depression—and are less likely to receive care. “Right now, treatment is really reactive. We wait and see who gets sick and then we treat,” Payne says.

Judite Blanc, an assistant professor of psychiatry and behavioral science at the University of Miami Miller School of Medicine, says a pill is not a magic solution, because it addresses only the chemical component of postpartum depression, not risk factors such as a lack of social support or poor partner relationships. “To me, the increase in postpartum depression in modern society is a reflection of all the pressures and social demands on women’s shoulders,” she says, adding that mothers need help with the demands of childcare. “We need a deep transformation of society.”

Update 8-7-2023 at 2:30 PM: This story was updated to reflect the FDA's decisions made on August 4.

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