New Moms Can Soon Take a Pill for Postpartum Depression
The FDA approved the first oral medication to treat the serious mental condition on Friday
Approximately one in eight new moms suffer from postpartum depression, an often debilitating condition that can cause women to feel anxious, withdrawn, sad and even suicidal after giving birth.
Soon, though, they’ll have a new treatment option. On Friday, the U.S. Food and Drug Administration (FDA) approved the first oral pill specifically designed to treat postpartum depression.
The medication, called zuranolone, will be sold under the brand name Zurzuvae. With a prescription from their doctor, people suffering from postpartum depression will take the pill once a day for two weeks.
The medication should become available in about three months, after the Drug Enforcement Administration reviews it. Drugmakers have not yet revealed what Zurzuvae will cost.
“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,” says Tiffany R. Farchione, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, in a statement. “And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development.”
The @US_FDA just approved the first oral medication indicated to treat postpartum depression in adults. https://t.co/jDNFI2HktH https://t.co/YQ9PIiez8x
— National Institute of Mental Health (NIMH) (@NIMHgov) August 7, 2023
The new pill, which was co-developed by Sage Therapeutics and Biogen, is the first of its kind. Currently, the only existing medication for postpartum depression is a 60-hour intravenous (IV) drip that must be administered in a doctor’s office or hospital. That option, called Zulresso, became the first postpartum depression medication to be approved by the FDA in 2019. But its high cost—around $34,000—and the time commitment involved, especially when mothers are tending to their newborns, have so far made it unpopular. Only around 1,000 patients have taken the drug so far, per the New York Times’ Pam Belluck.
Beyond that, the estimated 400,000 American women who suffer from postpartum depression each year often turn to general antidepressant medications, therapy, counseling and other mental health solutions. But general antidepressant drugs are not ideal, as they can take several weeks to start working.
“Many women will be very eager for a rapidly acting antidepressant,” such as zuranolone, says Samantha Meltzer-Brody, director of the Center for Women’s Mood Disorders at the University of North Carolina at Chapel Hill and one of the investigators for zuranolone’s clinical trials, to CNN’s Jacqueline Howard. “The postpartum period is such a vulnerable time.”
Both the new pill and the 60-hour IV drip contain a synthetic version of allopregnanolone, a chemical that occurs naturally within the body. During pregnancy, levels of allopregnanolone rise naturally, but then they drop off sharply after the birth of the child. Scientists say this sudden drop may contribute to postpartum depression.
Boosting allopregnanolone levels, then, should help alleviate the condition. In clinical studies of zuranolone, women who took the pill experienced more relief from their symptoms compared to those who took a placebo: Right after the 14 days of treatment, 57 percent of participants who took zuranolone reported a 50 percent or higher improvement in their symptoms, while only 38 percent of participants who took the placebo reported the same, per CNN. The pill can start working in as little as three days, and its effects lasted through 45 days after treatment stopped.
Sahar McMahon, a 39-year-old mother who gave birth to her second child in 2021, decided to participate in one of the studies after she began feeling like she wanted to avoid her children, she tells the Associated Press’ Matthew Perrone. Within a few days of taking the pill, she says her mood began to improve.
“It was a quick transition for me just waking up and starting to feel like myself again,” she tells the publication.
However, doctors and mental health professionals caution that drugs like zuranolone won’t be a fix-all for all women. Researchers only tested the pill on women suffering from severe postpartum depression, so it’s unclear how it will work for those with mild or moderate depression. Since the price is still unknown, it’s also unclear whether it will be affordable enough to be practical.
In addition, some healthcare providers are concerned that women with all levels of severity of postpartum depression will take the pill instead of first pursuing other types of treatment, such as therapy or behavioral and lifestyle changes, which doctors generally recommend for mild or moderate symptoms.
Beyond that, healthcare providers also say additional testing is needed to see how the pill affects mothers and babies long-term. Researchers did not test the pill on breastfeeding mothers, for instance.
Zurzuvae also comes with some side effects, such as dizziness, fatigue, drowsiness, urinary tract infection, suicidal thoughts and others, per the FDA statement. The agency says women should not drive or operate heavy machinery within 12 hours of taking the drug.
Still, most heralded the FDA approval as a big victory for maternal health. With a fast-acting, easy-to-take treatment option available soon, more new moms might be willing to admit they have postpartum depression and ask for help.
“This is a patient population that just so often falls through the cracks,” says Ruta Nonacs, a psychiatrist with the Center for Women’s Mental Health at Massachusetts General Hospital, to the New York Times.