On August 4, the U.S. Food and Drug Administration (FDA) approved the first oral pill for the treatment of postpartum depression—a condition that can impact up to 100,000 women a year in California.
Postpartum depression is a maternal mental health condition that can occur during pregnancy or after birth. The condition includes feelings of sadness, worry and fatigue that can impact daily life. Postpartum depression is the most common complication for women who have just had a baby, according to the March of Dimes, a nonprofit organization focused on maternal health justice.
The FDA’s approval of zuranolone, sold under the brand name Zurzuvae, as the first oral medication to specifically treat symptoms of postpartum depression in adults is significant as treatment for the condition was previously only available by an intravenous injection of brexanolone administered in health care facilities.
According to the California Department of Public Health (CDPH) data from 2018, one in five women who recently gave birth experienced symptoms of depression during or after pregnancy.
“Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings,” Tiffany R. Farchione, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, said in a statement.
The pill was proven to be effective in clinical trial studies in which women diagnosed with postpartum depression were given Zurzuvae or a placebo over a 14-day period. Results found that patients given Zurzuvae “showed significantly more improvement in their symptoms compared to those in the placebo groups.”
In Phase 3 of the SKYLARK study of zuranolone, data showed that 57% of the women who took zuranolone versus 38% of women who received the placebo experienced a 50% or more improvement in their depressive symptoms at day 15, according to the American Journal of Psychiatry.
While the approval of Zurzuvae is expected to have an impact on those experiencing postpartum depression, health advocates recognized that the clinical trials included a majority of people who experienced more severe cases of postpartum depression instead of mild symptoms.
The recommended dose for Zurzuvae is 50mg and should be taken once daily for 14 days in the evening “with a fatty meal.” Some common side effects of the medication include dizziness, fatigue and urinary tract infection. The FDA also noted that the use of Zurzuvae may cause suicidal thoughts and behavior.
The medication’s manufacturers, Sage Therapeutics and Biogen, have also submitted an application to the FDA for the approval to use the drug to treat major depressive disorder (MDD), a mental health condition that causes a persistently depressed mood.
“The approval of ZURZUVAE to treat postpartum depression is a major milestone for the hundreds of thousands of women who experience this underdiagnosed and undertreated condition,” said Christopher A. Viehbacher, president and chief executive officer, at Biogen in a press release.
According to Sage and Biogen, the FDA said that the application “did not provide substantial evidence of effectiveness to support the approval of zuranolone for the treatment of MDD and that an additional study or studies will be needed.”
This article is published as part of the Commonwealth Fund Health Equity Reporting Fellowship.