This week, the United States Food and Drug Administration approved a groundbreaking new drug that has the potential to help hundreds of thousands of new mothers suffering from the most common medical complication of childbirth: postpartum depression, or PPD.
One in nine new mothers in America experiences PPD, according to the Centers for Disease Control and Prevention—a figure that varies by state and can rise to as many as one in five in some places. Its symptoms can range from anger, isolation, and anxiety to, in some cases, thoughts of hurting yourself or your newborn.
"One of the things about treatment for postpartum depression is it really has to do with establishing attachment between mother and baby," says Dr. Margaret Spinelli, a clinical professor of psychiatry at Columbia University who was not involved in the drug's development.
Brexanolone (marketed as Zulresso) is an injection shown in clinical trials to reduce the symptoms in women with moderate to severe PPD in as little as 24 hours, and to last as many as 30 days. The timeline is significant: Typical antidepressants can take weeks to take effect, time that can be crucial for bonding between parents and their new children. "If the depression is prolonged, both the mother and the baby lose out," Spinelli explains, "whereas this puts them together almost immediately."
"There's been nothing else that's been made specifically for postpartum disorders," she adds. "I think it's great."
Will Those Who Need the Treatment Be Able to Afford It?
But there are significant drawbacks. The drug is administered by injection over 60 consecutive hours, or about two and a half days. Common side effects include sleepiness, dry mouth, flushing of the skin, and passing out. The FDA considered the loss of consciousness a serious enough risk to require the drug only be administered at a limited number of health-care facilities "where the health-care provider can carefully monitor the patient," Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, said in a statement.
And then there's the question of whether the women most likely to need it will be able to afford it. The drug is estimated to cost $34,000 per patient. Sage Therapeutics, the drug's manufacturer, told the New York Times it expects insurers will cover the drug, which should available in June. The Times reports that insurance companies are "evaluating" it, and there's been no word as to whether it will be covered by Medicaid.
At the crux of such a high price tag isn't just the assumption that only the very wealthy will be able to pay for it out-of-pocket—there's also the fact that women with lower socioeconomic status are among those at a higher risk for developing postpartum depression, and the fact that about 45 percent all births in America are paid for by Medicaid.
Numerous studies have established links between socioeconomic status and PPD. One found that women with four specific factors—low incomes, less education, being unmarried and unemployed—are 11 times more likely to develop symptoms of PPD. Women on Medicaid benefits, as well as pregnant teenagers, those with unwanted pregnancies, and those who have a history of domestic violence or lack of partner and social support are also at a greater risk.
Dr. Samantha Metzer-Brody is the director of the Perinatal Psychiatry Program at the University of North Carolina's Center for Women's Mood Disorders, and the primary investigator of brexanolone. "Obviously for women of low [socioeconomic status] they will need to have insurance coverage of the drug. So given that 50 percent of all births are [paid for with] Medicaid, that will be an important piece to see how that plays out," she says.
"We had many women of lower socioeconomic status in our studies, and any drug that can work quickly and relieve suffering and get mom back to functioning—and for women of lower socioeconomic status that often means back to work very quickly—is enormously important," she adds. "I think it can make a huge difference in treating people quickly so that moms can interact with their babies, they can get back to work, they can do what they need to do."
What Could This Drug Mean for Women of Color and Women's Health Overall?
Metzer-Brody sees the drug not just as an "exciting step forward" for PPD, but for women's health.
"There's a complete neglect of women's health in general, you add that to the fact that mental health is often neglected and then you put those two together and throw in the perinatal period, and it has been understudied, under-diagnosed, and under-treated like so many things in women's health," she says.
Research shows nearly 60 percent of women with PPD don't receive a clinical diagnosis, and 50 percent don't receive treatment.
It took Kay Matthews eight months to get help. It was 2013, and she'd given birth to a stillborn daughter. On top of the grief of losing her baby—and the way her body still produced milk and continued to behave as if the child had lived—something else seemed to be lost too.
"Something is wrong," she remembers thinking. "Let's put the baby to the side, something is wrong with me. What happened to the person I used to be?" Eventually, Matthews was diagnosed with postpartum depression. Even then, she said, as a black woman, she couldn't find the kind of support she needed. The experience led her to launch a non-profit that helps pregnant teenagers, and that led to the founding of the Shades of Blue Project, dedicated to helping minority women with PPD or anxiety. She's also a partner in the Black Mamas Matter Alliance, an advocacy group that fights to improve black maternal health.
Matthews, who lives in Houston, says she's been one of a number of community advocates working with Sage's patient advocacy group for the past two years. She says she reached out to the company after hearing that they were developing a PPD drug, and she says the price tag has garnered a lot of discussion in that group. Still, she believes the drug is a step in the right direction. She expects Sage will introduce a program to help patients pay for the drug, and she says there's time for insurance companies to cover it.
"There are so many other things that cost too much, yet we make them happen," she says. "It's not a cure for all, just like any other medication. It's not magic, it just helps. That's the realest way I can say that."
Matthews describes ongoing stigma around mental health in the black community, the way new mothers suffering from PPD can often just assume that it's normal to have those symptoms. There remains a barrier around talking about feelings that can be hard to overcome.
"I think we are making progress," she says, and she believes the new drug is part of that. "It's that these women can get their lives back. When a woman experiences postpartum depression, when you're not yourself and you're in this dark place and you don't know how to get out of it, that's devastating. And you miss out on the best part of life, including your baby's life."
"Two and a half days in a hospital" receiving this new drug, she says, "and you're able to regain some type of stability back."