In a first, FDA approves fast-acting postpartum depression pill

One in eight women will experience postpartum depression (PPD), in which new mothers experience feelings of hopelessness or withdrawal after delivery, sometimes not feeling affection for a new child. In the U.S., suicide is the leading cause of maternal mortality in the first postpartum year.

Despite how common PPD is and the risks it presents, there is only one drug approved to treat it, which must be administered through an IV drip over the course of 60 hours. Known as brexanolone, it was approved by the U.S. Food and Drug Administration (FDA) in 2019, but the risk of excessive drowsiness or sudden loss of consciousness has made administering it a challenge.

That is set to change following the FDA's Friday approval of the first-ever pill for PPD a drug called zuranolone.

"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," said Dr. Tiffany R. Farchione, the director of the Division of Psychiatry in the FDA's Center for Drug Evaluation and Research in a press release. "Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings."

Zuranolone, made by Sage Therapeutics and Biogen and sold under the brand name Zurzuvae, is to be taken with food for 14 days, according to the FDA press release. The regimen for taking zuranolone has been likened to an antibiotic, with a relatively short and fast-acting course. 

In clinical studies submitted to the FDA, people who took zuranalone had significantly improved symptoms of depression and anxiety after just three days, with the effects sustained one and a half months out. The idea is that one course of zuranalone can be administered to those with PPD, who then can decide with their doctor if another dose of medication or complementary treatments like talk therapy are necessary, said lead study author Dr. Kristina Deligiannidis, a professor at the Institute of Behavioral Science at the Feinstein Institutes for Medical Research in Manhasset, New York.

"Research indicates only about 10% of women with PPD receive clinically adequate treatment, so that's an adequate dose and duration of either talk therapies and/or a standard of care antidepressant," Deligiannidis told Salon in a phone interview. "The majority of women aren't even accessing our standard of care."

Mild cases of PPD have historically been treated with talk therapy, while moderate to severe cases are typically treated with additional antidepressants, especially of the SSRI (selective serotonin reuptake inhibitor) class like Zoloft, Prozac, or Lexipro). But these drugs can take up to 12 weeks to start working, Deligiannidis said. 

Many folks also don't see it as practical to spend two or three days in the hospital receiving intravenous broxanalone when they have a new infant at home, she added. Others can't afford the treatment, as the drug costs about $38,000 per patient. Sage has not yet reported what the price of the new zuranolone pills will be.

Zuranolone is in the same drug family as broxanalone, also known by the brand name Zulresso. Both are similar to allopregnanolone, a naturally occurring neuroactive steroid that binds to GABA receptors within the brain. It is thought to work by stabilizing allopregnanolone levels that change during and after pregnancy.

Some of the major side effects in studies testing zuranalone in women with PPD were drowsiness, dizziness, and fatigue, along with diarrhea, the common cold and urinary tract infections. Patients are advised not to drive up to 12 hours after taking zuranalone due to these side effects.

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The FDA also warned that zuranalone "may cause fetal harm," as there isn't much information on how the drug is passed between mother and infant while breastfeeding: In the two main studies submitted for approval, women were advised to stop breastfeeding during the treatment period, although another study showed very little of the drug appeared in breastmilk after five days of treatment.

Sage and Biogen also applied to get zuranolone approved for the treatment of major depressive disorder (MDD), which affects a much broader portion of people, but the FDA said the applications of the drug companies "did not provide substantial evidence of effectiveness to support the approval of zuranolone for the treatment of MDD," and asked for more data, according to a press release.

Although the American College of Obstetricians and Gynecologists (ACOG) does not yet have guidance on zuranolone, "addressing mental health issues are of paramount importance to ACOG," said Dr. Christopher Zahn, ACOG's interim CEO and chief of Clinical Practice and Health Equity and Quality.

"It is encouraging that postpartum individuals may now have more options to manage a debilitating condition that affects them and their families," Zahn added in an email statement to Salon.