Brexanolone was designed to address an unmet medical need. It’s also complicated to use.
About one in seven women who have a baby go on to experience the black cloud of postpartum depression. More intense and persistent than the “baby blues,” PPD, as it’s known, can strain a mom’s ability to care for herself and her new baby, flooding her with a paralyzing, “breathtaking sadness,” as one mom called it.
To date, there’s been no antidepressant specifically designed for these new moms. So many women are prescribed drugs that were approved for the general population. That means it’s not clear they’re safe or effective, and they don’t always work.
On Tuesday, the Food and Drug Administration approved brexanolone. Sold under the brand nameZulresso, by Sage Therapeutics, it’ll be the first drug targeting moms with postpartum depression when it hits the market, probably in late June. The medication, which is given intravenously by infusion, seems to act much faster than other antidepressants: within three days as opposed to weeks. Women who received the drug in clinical studies also reported their mood was better for up to a month after the infusion.
“Postpartum depression is a serious condition that, when severe, can be life-threatening. Women may experience thoughts about harming themselves or harming their child,” said Tiffany Farchione, the acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “This approval… [provides] an important new treatment option.”
But the new drug also requires a lot of women: their time and money. And ultimately, brexanolone’s costs may be too prohibitive to reach the moms who’d benefit most.
The drug costs $34,000 per patient without insurance, according to Sage Therapeutics. Even if a woman prescribed the drug can find a way to pay for it, or her insurance company decides to cover it, she would need to check herself into a hospital or clinic that’s certified to deliver brexanolone, and stay connected to an infusion drip for 60 hours under medical supervision. Brexanolone also has side effects, including passing out. So women need to be constantly accompanied by someone else if they bring their newborns with them.
Still, for the subset of women with very severe postpartum depression, the drug could be a “game changer,” said Lucy Puryear, medical director of Center for Reproductive Psychiatry at Texas Children’s Pavilion for Women in Houston, who was not involved with any clinical studies of the drug. “These are women who often are thinking about dying,” she said. “They aren’t able to function, aren’t getting out of bed.” Let’s walk through what we know about brexanolone and why it’s garnered a mixed reception.
Postpartum depression is believed to be the most common complication of childbirth, affecting 15 percent of new moms shortly before or within a year after delivery. While the disorder can manifest differently in each woman, the National Institutes of Health describes symptoms including feeling sad and hopeless, crying for no reason, anxiety, over- or under-sleeping, and experiencing changes in appetite.
