Last Friday, the FDA approved the first pill to treat postpartum depression, called Zurzuvae. Postpartum depression will affect one in seven people who give birth in the weeks after delivery, and can seriously affect the health of the parent and child. Previously, the only treatment was an expensive drug (brexanolone) that had to be administered via IV for 60 hours. In contrast, Zurzuvae is meant to be taken once a day for 14 days.

Figure 1. First Pill for Postpartum Depression Approved

First Pill for Postpartum Depression Approved is shown in Figure 1. Unlike antidepressants, the newly approved postpartum depression medication doesn’t target neurotransmitters like serotonin and dopamine. Instead, Zurzuvae is a derivative of progesterone, which can be unbalanced in the body after birth. It was tested on people with severe postpartum depression, not on those with more mild cases.

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“This is a patient population that just so often falls through the cracks,” said Dr. Ruta Nonacs, a psychiatrist with the Center for Women’s Mental Health at Massachusetts General Hospital. “When women are told, ‘You have postpartum depression,’ it’s embarrassing, it is demeaning, it makes them feel like a bad mom.”

She added, “There’s also a lot of stigma about taking antidepressant medication, so that might make this treatment more appealing because it’s really a treatment specific for postpartum depression.”

An estimated 10 to 15 percent of women who give birth in the United States experience depression during pregnancy or in the year afterward. The condition can be accompanied by intense anxiety, shame, guilt, impaired sleep, panic attacks and suicidal thoughts or attempts. And it can make it difficult for mothers to provide their babies with the care, bonding and nurturing that is crucial for healthy development.

“Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings,” Dr. Tiffany R. Farchione, the director of the F.D.A. division responsible for the approval, said in a statement.

The pill, zuranolone, which will be marketed under the brand name Zurzuvae, was developed by Sage Therapeutics, a Massachusetts company that produces it in partnership with Biogen. It is expected to be available after the Drug Enforcement Administration completes a 90-day review required for drugs affecting the central nervous system, Sage said. The companies have not announced a price for the pill.[2]

How zuranolone compares to the existing postpartum depression treatment

The FDA included a warning on the new drug label that patients shouldn’t drive or operate heavy machinery for at least 12 hours after taking the pill because they may not realize how impaired they are.

Zuranolone, however, offers several advantages over the existing treatment for postpartum depression, which is Zulresso (brexanolone), according to the experts interviewed.Although 70% of women see an improvement in their symptoms within 24 hours of receiving the Zulresso injection, Meltzer-Brody said, it takes 60 hours to administer.

The treatment is “not convenient to say the least, but pretty transformative,” she said. Zulresso also carries a risk of excessive sedation or sudden loss of consciousness — side effects that were not observed in trials of zuranolone. Nor did the zuranolone trials find the classic side effects of antidepressants, such as sexual dysfunction, weight gain, sleep disturbance or an increased risk of suicidal thoughts, according to Anita Clayton, the national principal investigator for two zuranolone trials in people with clinical depression.

The main side effects included drowsiness, dizziness, sedation, headache, nausea and diarrhea.For people with mild or moderate postpartum depression, however, psychotherapy is still the go-to treatment. Some are prescribed antidepressants, but Meltzer-Brody said zuranolone may be preferable because it seems to improve symptoms more quickly. “If you asked any new mother who’s having postpartum depression, ‘Would you like something that can work in days, or would you rather take weeks to months?’ most people really don’t have to think about that very long,” she said.[3]

References:

1. https://www.sciencefriday.com/segments/fda-approves-postpartum-depression-pill/
2. https://www.nytimes.com/2023/08/04/health/postpartum-depression-pill-fda.html
3. https://www.nbcnews.com/health/health-news/first-pill-postpartum-depression-fda-approval-rcna97731

Cite this article:

Gokula Nandhini K (2023), First Pill for Postpartum Depression Approved, AnaTechmaz, pp.463