The US Food and Drug Administration has approved the first pill that can be used specifically to treat postpartum depression, a move that will give patients more convenient access to fast-acting medication that addresses severe cases. The announcement marks a vital step in the treatment of postpartum depression, a debilitating condition that has long been underdiagnosed and that is often left unaddressed.
Tiffany Farchione, the head of psychiatry in the FDA’s Center for Drug Evaluation and Research, described postpartum depression as “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,” in a statement. Roughly one in seven women who’ve given birth can develop postpartum depression, according to the American College of Obstetricians and Gynecologists, and 50 percent of cases are not diagnosed due to gaps in screening or reporting.
The newly approved pill, which is known as zuranolone and will be sold by Sage Therapeutics using the brand name Zurzuvae, adds to existing treatments for postpartum depression. Currently, brexanolone has also been approved for this purpose, but it must be administered via intravenous injection during a 60-hour stay in a hospital or medical practice.
Zuranolone works by improving a person’s levels of allopregnanolone, a neuroactive steroid that can increase during pregnancy and dip steeply afterward. Those declines can lead to symptoms of depression including feelings of sadness, lack of energy, and, in more serious cases, thoughts of self-harm and harming others.
Zuranolone has been found to take effect within three days of ingestion and to have a positive impact that lasted for weeks afterward in studies. That makes it different from general anti-depressants that have also been prescribed to treat postpartum depression in the past, such as Zoloft and Cymbalta, which typically operate by boosting a person’s serotonin levels. Those, however, tend to work much more slowly and can require multiple weeks to take effect.
Experts caution that the trials of zuranolone have predominantly been with people who have experienced more severe cases of postpartum depression, so the medication may not be the best option for those with mild to moderate cases. They also note that it’s important to address structural factors that increase women’s chances of experiencing postpartum depression, like health care costs and discriminatory medical treatment, and to use other tools, like therapy, to address mental health challenges rather than relying solely on medication as a cure-all.
Zuranolone’s side effects include affecting a person’s ability to drive and other hazardous activities as well as drowsiness, dizziness, diarrhea, fatigue, the common cold, and urinary tract infection. It could also cause suicidal thoughts and behavior, as well as fetal harm. Additionally, the impact it could have on breastfeeding children is unknown. This FDA approval, though, is significant.
“Rapidly acting antidepressant therapies are needed and this would be the first oral drug formulation of a rapidly acting antidepressant. That is a very big deal for moving the bar forward to improve treatment options for women with postpartum depression,” Samantha Meltzer-Brody, director of the Center for Women’s Mood Disorders at the University of North Carolina at Chapel Hill, told CNN.
Postpartum depression has often been overlooked. This is one step to try to address that.
There are mixed conclusions about how postpartum depression differs from other clinical depression cases, with some research finding that cases that take place shortly after a woman gives birth are caused by unique hormonal changes. The new drug works in part by focusing on those changes.
“It has long been hypothesized that [postpartum depression] is related to the sensitivity some women have to the dramatic changes in hormones from pregnancy to postpartum. Zuranolone is targeting these hormonal changes that are unique to the perinatal period,” Catherine Monk, a professor in women’s mental health at Columbia University, told Vox.
The fact that it has taken so long to approve a pill specifically for this purpose is in part because women have been neglected in medical research for years, and postpartum depression is among the conditions that haven’t received sufficient attention and focus. Additionally, women of color and low-income women are more likely to experience postpartum depression than white women and wealthy women, and they’ve historically been marginalized by medical institutions when it comes to both treatment and research.
Beyond these factors, there has also been less of a focus on mental health from corporations.
“Pharmaceutical companies are reported to be less invested in psychiatric medications than in other disease conditions, in part due to the science challenges,” says Monk. Those challenges mean higher drug development costs and a greater degree of financial risk — money spent on research doesn’t necessarily lead to a viable product.
The emergence of zuranolone comes as more awareness has been raised about this condition and as more of a spotlight has been put on how mental health-related struggles are now the most common cause of pregnancy-related deaths.