In August the Food and Drug Administration approved Zurzuvae (zuranolone), the first oral medication to treat postpartum depression. The approval is a big step for women with the condition, which affects approximately 1 in 7 new mothers.
“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," Dr. Tiffany Farchione, director of the psychiatry division in the FDA’s Center for Drug Evaluation and Research says in a release. "And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional 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.”
There's a lot to unpack with this approval, including for whom Zurzuvae is designed for and how it works. Here's what you need to know.
Why is treating postpartum depression so important?
Postpartum depression is a condition that can cause intense feelings of sadness, anxiety or despair that prevent new mothers from being able to do their daily tasks, according to the American College of Obstetricians and Gynecologists (ACOG). It generally starts one to three weeks after a woman gives birth but can happen up to a year after having a baby, the ACOG says.
“Postpartum depression hits at a critical time when sleep and self-care abilities are at a minimum,” Dr. Tamar Gur, a women’s health expert and reproductive psychiatrist at the Ohio State University Wexner Medical Center, tells Yahoo Life. “Depression can also impact families, and it’s a critical time for the infant as well as the family as a whole.”
Researchers are still learning more about why some women develop postpartum depression while others don't, but the ACOG says the condition is likely influenced by several factors, including changes in hormone levels in the postpartum period, a history of depression, emotional factors, fatigue and lifestyle factors, like a lack of support from others and stressful life events.
“Right now, treatment options for postpartum depression include regular antidepressants,” women's health expert Jennifer Wider tells Yahoo Life. Having a specific pill for postpartum depression “is a game changer for women, who often suffer in silence,” Wider says.
Women with severe postpartum depression also have the option of Zulresso, 60-hour IV infusion of brexanolone, but the treatment can’t be done at home, Gur says.
The approval of this new medication can help alleviate the stigma associated with postpartum depression, Hillary Ammon, a clinical psychologist at the Center for Anxiety & Women's Emotional Wellness, tells Yahoo Life. “Some women find it shameful to discuss their struggles, while others may be scared to take medication for these issues,” she says. “A medication developed specifically for depression in the postpartum phase may help reduce the stigma associated with talking about and receiving treatment for postpartum depression.”
How is the postpartum depression pill different from other depression medications?
Depression is often treated with selective serotonin reuptake inhibitors (SSRIs), but Zurzuvae is not an SSRI. “This mechanism is very different,” Jamie Alan, an associate professor of pharmacology and toxicology at Michigan State University, tells Yahoo Life. “This works like endogenous neurosteroids and its effect is immediate.” By comparison, Alan says, SSRIs usually take between four and six weeks to have a full effect.
Zurzuvae went through several clinical trials, including a phase III clinical trial that was recently published in the American Journal of Psychiatry. For the trial, 196 women with severe postpartum depression were given a 50-milligram dose of Zurzuvae in pill form or a placebo. Those in the Zurzuvae group had “significant improvements in depressive symptoms” compared to those in the placebo group within 14 days, the researchers found. The results were also consistent 28 and 45 days later, the researchers found.
Are there any issues with Zurzuvae and breastfeeding?
The clinical trial involved only mothers who were not breastfeeding, so it is not currently recommended for nursing moms. That doesn’t mean it’s not safe to use while breastfeeding — it just hasn’t been studied or determined yet.
Who is Zurzuvae for?
Zurzuvae is intended for women with severe postpartum depression. It’s also a good option for those who prefer the convenience of a pill rather than an IV infusion, which can take days.
“This is absolutely a step forward,” Gur says.
How much will it cost?
In November, the drugmaker Sage Therapeutics revealed that Zurzuvae is expected to be available this December. But, as CNN reports, there are already concerns about its cost: $15,900 per 14-day course, before insurance. According to Sage CEO Barry Greene, the drug company and partner Biogen are discussing coverage plans with insurers to "enable broad and equitable access for women with PPD who are prescribed this drug." Greene added in a news release that the goal is for women to access the medication "with little to no co-pay," and that the two companies will offer financial support for qualifying patients.
This article was originally published on Aug. 4, 2023 and has been updated.