In August, the Food and Drug Administration approved Zurzuvae (zuranolone), the first oral drug to treat postpartum depression. The approval is a big step for women with the disease that affects them 1 of 7 new mothers.
“Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt and worthlessness – in severe cases, even thoughts of harming themselves or their child,” says Dr. Tiffany Farchione, chief of the FDA’s Psychiatry Division Center for Drug Evaluation and Research, says in a press release: “And because postnatal depression can disrupt the mother-infant bond, it can also have consequences for the child’s physical and emotional development.” For many of these women struggling with extreme and sometimes life-threatening emotions, access to an oral medication will be a beneficial option.”
There’s a lot to reveal with this approval, including who 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 completing their daily tasks, the study found American College of Obstetricians and Gynecologists (ACOG). According to ACOG, it generally begins one to three weeks after a woman gives birth, but can occur up to a year after the birth of a child.
“Postpartum depression occurs at a critical time when sleep and self-care skills are at a minimum,” explains Dr. Tamar Gur, a women’s health expert and reproductive psychiatrist at The Ohio State University Wexner Medical Center, told Yahoo Life. “Depression can also impact families, and it is a critical time for the child and the entire family.”
Researchers are still learning more about why some women develop postpartum depression while others do not. However, according to ACOG, the condition is likely influenced by several factors, including changes in hormone levels in the postpartum period, a history of depression, emotional factors and fatigue, and lifestyle factors, such as lack of support from others and stressful life events.
“Current treatment options for postnatal depression include regular antidepressants,” says the women’s health expert Jennifer Wider tells Yahoo Life. Having a special pill for postpartum depression “is a game-changer for women who often suffer in silence,” says Wider.
Women with severe postpartum depression also have the opportunity to do this Zulresso60-hour IV infusion of brexanolone, but the treatment cannot be done at home, says Gur.
The approval of this new drug may help ease the stigma associated with postpartum depression, says Hillary Ammon, a clinical psychologist at Center for Women’s Anxiety and Emotional Wellbeing, tells Yahoo Life. “Some women find it shameful to talk about their problems, while others may be afraid to take medication for these problems,” she says. “A medication specifically designed for depression in the postpartum period may help reduce the stigma associated with speaking out and treating 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, associate professor of pharmacology and toxicology at Michigan State University, tells Yahoo Life. “This works like endogenous neurosteroids and its effects are immediate.” By comparison, says Alan, SSRIs typically take between four and six weeks to take full effect.
Zurzuvae underwent several clinical trials, including a Phase III clinical trial recently published in the American Journal of Psychiatry. For the study, 196 women with severe postpartum depression received a 50-milligram dose of Zurzuvae in pill form or a placebo. Researchers found that participants in the Zurzuvae group had “significant improvements in depressive symptoms” within 14 days compared to those in the placebo group. The results were consistent 28 and 45 days later, the researchers noted.
Are there any problems with Zurzuvae and breastfeeding?
The clinical trial only included mothers who were not breastfeeding, so it is not currently recommended for breastfeeding mothers. This doesn’t mean it’s not safe to use while breastfeeding – it just hasn’t been studied or established yet.
Who is Zurzuvae suitable 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 over an intravenous infusion, which can take days.
“This is absolutely progress,” says Gur.
How much will it cost?
In November, drugmaker Sage Therapeutics announced that Zurzuvae was expected to be available in December. But as CNN reports, there are already concerns about the cost: $15,900 per 14-day course, without insurance. According to Sage CEO Barry Greene, the pharmaceutical company and its partner Biogen are discussing insurance plans with insurers to “provide broad and equitable access to women with PPD who are prescribed this medication.” Greene added: Press release The goal is for women to have access to the medications “with little to no out-of-pocket costs,” and for the two companies to offer financial assistance to qualified patients.
This article was originally published and updated on August 4, 2023.