FDA Approves Zurzuvae: The First Oral Treatment for Postpartum Depression
BREAKING NEWS — For immediate release.
August 4, 2023
The Food and Drug Administration approved Zurzuvae, also called zuranolone, which is a new drug specifically designed to treat postpartum depression (PPD).
Zuranolone is an oral tablet taken for 14 days and has been proven to significantly reduce the symptoms of postpartum depression.
Early studies of zuranolone showed significant improvements in the safety and effectiveness in treating postpartum depression compared to standard treatments.
The FDA has given zuranolone priority review and fast track designation in order to make this drug available to patients in need sooner than the standard review process.
Postpartum depression impacts approximately 1 in 7 women in the first year following pregnancy, and it is one of a range of perinatal mental health (PMH) conditions, which also include anxiety, obsessive-compulsive disorder, post-traumatic stress disorder, bipolar disorder, and substance use disorders. Together, these perinatal mental health conditions impact 1 in 5 pregnant or postpartum people (800,000 individuals) each year in the United States.
An article published in the American Journal of Psychiatry in July 2023 shared results from a two-year study that included 196 women with severe postpartum depression. The study found that women who took a daily 50-milligram dose of zuranolone for 14 days showed “significant improvements in depressive symptoms” compared with those who were given a placebo. These improvements were still noted at 28 and 45 days following the end of treatment.
Dr. Kristina Deligiannidis, a professor at the Institute of Behavioral Science at the Feinstein Institutes for Medical Research in New York, was the lead author on the study. According to Dr. Deligiannidis, “The greatest benefits of zuranolone are its rapid antidepressant effects, short at-home treatment course, and generally well-tolerated side effect profile.”
Zuranolone is only the second drug developed specifically to treat postpartum depression. In 2019, the FDA approved the use of brexanolone, which is administered as a 60-hour inpatient infusion. Both zuranolone and brexanolone are versions of allopregnanolone, a naturally occurring metabolite of the hormone progesterone.
Levels of progesterone rise dramatically during pregnancy and then abruptly drop after childbirth, potentially contributing to postpartum depression. It has long been thought that some women are particularly sensitive to this precipitous drop in progesterone, leading to postpartum depression.
Source: The McGill Physiology Virtual Lab, Biochemical/Molecular Techniques, Background Concepts: Reproduction Hormones
According to MMHLA Executive Director Adrienne Griffen, “Having a medication that is easy to take and has such a rapid effect could be a game-changer for those experiencing postpartum depression.”
Typical antidepressant medications, which have long been used to treat postpartum depression, can take several weeks to reach therapeutic levels, and not all antidepressants work the same way, causing some women to have to try multiple medications to achieve symptom relief.
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