On August 4, the United States Food and Drug Administration (FDA) approved zuranolone to treat postpartum depression. The medication is now the first FDA-approved oral pill available in the US to treat postpartum depression. The serious mental illness can develop in roughly 1 in 7 new mothers following childbirth and is one of the leading causes of maternal mortality.
The first-of-its-kind treatment will be sold under the brand named Zurzuvae and is a once-daily pill taken over 14 days.
“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. And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development,” director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research Tiffany R. Farchione said in a statement. “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”
Some of the depression symptoms common in new mothers include changes in appetite and sleep. However clinicians say the more severe symptoms that might signal postpartum depression include feelings of sadness, hopelessness, guilt, or worthlessness in addition to trouble bonding with the baby. Severe symptoms can include suicidal thoughts.
Postpartum depression often ends on its own within a few weeks, but it can continue for months or even years. The standard course of treatment includes talk therapy and/or antidepressants, which do not help everyone and can take weeks to work.
The FDA’s pill approval is based on two company studies that demonstrated that new moms who took Zurzuvae had fewer signs of depression over a four- to six-week period, compared with those who did not take the medication. The benefits were measured by a psychiatric test and appeared within only three days for many of the patients in the trial.
As part of the approval, the FDA added a warning to Zurzuvae’s labeling indicating that it can impact the ability to drive, and patients may be able to assess how impaired they are by the drug. The FDA says patients should not should not drive or operate heavy machinery for at least 12 hours after taking the medication. Zurzuvae’s most common side effects include dizziness, drowsiness, fatigue, diarrhea, the common cold, and urinary tract infection. The FDA also said that it could cause suicidal thoughts and behavior, may also cause harm to a fetus, and that patients should use effective contraception while taking the drug and for a week after stopping.
Zurzuvae is manufactured by Sage Therapeutics, which has a similar infused medication called Zulresso that’s given intravenously over three days in a medical facility. Zulresso was approved by the FDA in 2019, but it is not widely used largely due to the logistics of administering it and the roughly $34,000 cost.
In February, the FDA accepted an application from Biogen and Sage Therapeutics for the approval of zuranolone and granted a priority review. The drug is part of an emerging class of medications from Sage called neurosteroids. These medications stimulate a different pathway in the brain than older antidepressants which target a chemical linked to emotions and mood called serotonin.
Kimberly Yonkers, a Yale University School of Medicine psychiatrist specializing in postpartum depression, told the Associated Press that Zurzuvae effect is “strong” and the medication will likely be prescribed in those who haven’t responded to treatment with antidepressants. However, she did say the FDA should have required more follow-up data on how patients fared after additional months of treatment.
“The problem is we don’t know what happens after 45 days,” said Yonkers, who was not involved in the study. “It could be that people are well or it could be that they relapse.”
All women should be screened for postpartum depression during the early days of a pregnancy, and a first step should be contacting an obstetrician or midwife for help if not screened. Additional resources for postpartum depression include the national maternal mental health hotline (1-833-852-6262) and Postpartum Support International.