The FDA Has Approved the First Postpartum Depression Drug—And It’s a Game-Changer

The FDA Has Approved the First Postpartum Depression Drug—And It’s a Game-Changer
Zulresso is the first drug approved by the FDA to treat postpartum depression, marking a vital new chapter for women’s reproductive health.

While the extraordinary joy that comes with motherhood is no secret, less talked about are the incredible stress and radical shifts in mood it can produce, catalyzed by the dramatic physical and physiological changes that new moms experience.

In fact, up to one in seven women suffer from the most extreme form of postnatal adjustment—postpartum depression—which is a severe form of clinical depression brought on by pregnancy and childbirth that can last for months or even years, according to the National Institute of Mental Health. Over the past two decades, major strides have been made in raising awareness of the common condition, from Brooke Shields’s groundbreaking 2006 book Down Came the Rain and even more illuminating 2017 documentary When the Bough Breaks to the growing list of fellow celebrities who have opened up about their own experiences with postpartum depression, including Serena Williams and Chrissy Teigen. But specialized medical treatment has been a different story, leaving much to be desired—until now.

On Tuesday, the FDA approved the first drug designed specifically to treat postpartum depression, marking a vital new chapter for women and physicians alike. Called Zulresso, the treatment is an IV infusion of brexanolone, a synthetic form of the hormone allopregnanolone, which is produced by progesterone in the brain and may help ease anxiety and depression. Administered in a single 60-hour session, clinical trials have shown it to successfully treat symptoms of postpartum depression within 48 hours. In fact, in a company-funded study of new mothers, half of the women given Zulresso had their moderate or severe postpartum depression end within two and a half days.

While promising, Zulresso, which will be available in June, is not without its problems. In addition to being time prohibitive for a new mom, there are also potential side effects, including headaches, dizziness, excessive sleepiness, and, in a few cases, loss of consciousness. But the biggest hurdle of all is cost. The initial list price for Zulresso in the U.S. will be $7,450 per vial with a projected average cost of $34,000 per patient over the course of treatment. According to the company that developed the drug, Sage Therapeutics, insurance coverage of the treatment will be determined by each insurance company and each individual’s plan.

Despite these shortcomings, it’s a big deal for the future of women’s health, says Alexandra Sacks, M.D., reproductive psychiatrist and coauthor of What No One Tells You: A Guide to Your Emotions from Pregnancy to Motherhood. Treating PPD today, doctors are most likely to prescribe antidepressants like Zoloft, which are designed to treat all kinds of anxiety and depression in men and women. “[Zulresso] works in a different pathway of the brain and, moreso than other antidepressants, the biochemical mechanism takes the hormones of the female reproductive cycle into consideration,” explains Sacks, adding that when a woman delivers a baby, her estrogen and progesterone levels shift dramatically; it’s that very sudden change that can be particularly triggering for women. Another major benefit? Its rapid results. While other antidepressants take about four weeks to work, those who respond positively to the new drug will get help quickly, Sacks underlines. “The longer a new mom is ill, the longer it’s a detriment to her safety and quality of life, as well as that of the baby, who’s in the early phases of attachment and bonding,” she explains. “If you’re not able to function, you can’t engage in basic self-care and childcare. The sooner we can get people well, the better it is for the whole family.”

While the far-reaching success of Zulresso will largely hinge on cost, it’s both an important breakthrough medically, with postpartum depression affecting about 400,000 American women a year, and hopefully a harbinger of more specialized treatment in women’s reproductive health to come. “What this drug shows is that we’re in a really cutting-edge time of medicine and beginning to understand how women’s bodies and brains have different needs,” says Sacks. The U.S. rate of maternal mortality—the highest in the developed world and one that disproportionately affects African-American women—is a sobering call to action, she adds.“Breakthroughs like this are an important reminder that as a culture, we need to keep moving women’s health forward.”

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