FDA Approves New PPD Drug

About 1 in 9 women experience postpartum depression (PPD), a serious mental illness that can develop any time within the first year after birth, though most commonly within a week to a month after delivery. In part thanks to celebrities like Serena Williams and Chrissy Teigen speaking out about their experiences, awareness around PPD is growing, but treatment has been limited to talk therapy with a mental health professional or medications prescribed for all kinds of depression, not just PPD.

Now, that’s changing. On Tuesday, March 19, the U.S. Food & Drug Administration (FDA) approved the first drug specifically for women suffering PPD. “Postpartum depression is a serious condition that, when severe, can be life-threatening,” Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products at the Food and Drug Administration’s Center for Drug Evaluation and Research, said in a statement. “This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option.”

Here’s everything you should know about this breakthrough. 

What is the new postpartum depression drug called and how do you get it?

Called Zulresso (generic name brexanolone), the medication is delivered through an infusion over the course of 60 hours, during which the mom receiving the treatment must stay in a certified medical center under supervision. The reason you have to stay in an approved medical center? Two possible side effects include dizzyness and fainting. During the drug’s two double-blind, placebo-controlled clinical trials, several patients experienced these symptoms. But the trials were otherwise promising in terms of the number of women the drug helped and the “near-instantaneous relief” Zulresso provided, according to NBC News. Many of the women in the trials had moderate to severe postpartum depression and saw an improvement of their symptoms within 24 hours of receiving the drug. What’s more, the improvement lasted 30 days after their infusion.

How is Zulresso different from other postpartum depression treatments?

Zulresso is different from other depression drugs like selective serotonin reuptake inhibitors (SSRIs) because it contains allopregnanolone, a synthetic version of progesterone. A woman’s progesterone levels nosedive after birth, which experts think that might contribute to postpartum depression.

How much does Zulresso cost? 

Zulresso comes with a gulp-inducing price tag: Sage estimates that it will cost $20,000 to $35,000 for the infusion. That does not include the cost of staying in the facility, and as of now, it’s unclear how much of the treatment — if any  — will be covered by insurance (insurance companies told the New York Times they’re “evaluating the drug this week”).

That said, Sage Therapeutics’ chief medical officer Steve Kanes, M.D., Ph.D, emphasized to NBC that it’s a one-time cost that provides a long-term effect, explaining, “That’s such an important piece as to why this is so novel. We’re talking about a single treatment that has durable effects. This really is a one-time intervention that gets people on their way. It’s transformative.”

Sage also told the Times that a pill version of Zulresso is also in the works (though it’s at least two or three years away from FDA approval).  

What do experts think of Zulresso?

The medical professionals What to Expect spoke to who are unaffiliated with the drug agree that these findings and the drug’s approval are revolutionary. “Because no FDA-approved antidepressants for postpartum depression existed until now, this first medication is a tremendously exciting breakthrough,” says Kristina Deligiannidis, M.D., director of women’s behavioral health at Northwell Health’s Zucker Hillside Hospital, and associate professor at Northwell Health’s Feinstein Institute for Medical Research. “We were thrilled with how the trials demonstrated antidepressant effects in a remarkably quick timeframe.”

Kimberly Yonkers, M.D., professor of psychiatry, epidemiology, and obstetrics, gynecology and reproductive sciences at the Yale School of Medicine, tells What to Expect she finds the treatment promising—with one caveat. “This medication potentially increases the time to improvement from depression, as well as the likelihood of improving, but at a cost,” she notes.

In the meantime, the drug is a huge step toward treating postpartum depression. As Samantha Meltzer-Brody, M.D., director of the perinatal psychiatry program at the University of North Carolina at Chapel Hill and the academic principal investigator in the brexanolone trials, tells NBC, “This is for postpartum depression, but it is a step in understanding how we treat depression more broadly. We have had the same treatments for depression for 30 years. There’s an enormous need for new, novel ways to treat depression, and to treat it quickly.”

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