When you’re pregnant, the promise is that motherhood will make you the happiest person on earth. That’s a far cry from reality for many women, but for the one in seven dealing with postpartum depression, the new-mother whiplash is much more severe. For these women, options are scarce. “Postpartum depression has been neglected—it’s been underdiagnosed and undertreated,” says Samantha Meltzer-Brody, M.D., director of the perinatal psychiatry program at the UNC Center for Women’s Mood Disorders. “So many women suffer. Screening is spotty, treatment is spotty, and it’s one of the greatest causes of maternal mortality.” So it’s groundbreaking news that this week the FDA officially approved the first postpartum-depression drug therapy.
The approval is a true game changer. Currently available treatments for postpartum depression, usually prescription antidepressants, can take anywhere from four to six weeks to start working. That may seem like a lifetime for a new mom suffering with severe symptoms. The new drug brexanolone, which will be sold under the name Zulresso by Sage Pharmaceuticals, starts working almost immediately. In clinical trials of women with moderate to severe postpartum depression, most women saw improvements within the first day, says Dr. Meltzer-Brody, the principal investigator for the trials. And women still felt relief 30 days after just one treatment.
So how does it work? “What’s really exciting in terms of postpartum depression is that this is a hormone-based therapy,” Dr. Meltzer-Brody says. Zulresso is a synthetic form of allopregnanolone, which the body makes as it breaks down the fertility hormone progesterone. During pregnancy, levels of progesterone reach all-time highs, but after giving birth, levels of the hormone drop quickly, which researchers think could be tied to postpartum depression. Zulresso is administered via an IV.
That’s where things get a bit trickier. The IV infusion lasts 60 hours, and women have to be monitored closely while the drug is being administered. That means for women to receive the treatment, they’ll have to check in to a certified medical center for two and a half days, a big chunk of time during those early days when a mother is still bonding with her newborn, or perhaps already back at work and juggling many demands on her time. But Dr. Meltzer-Brody says that women in the trial found those hours spent in the clinic to be a “minor inconvenience” compared with the precious weeks they’d otherwise have to wait for more traditional antidepressants to kick in. “For women who are depressed, who are not able to return to work, who are not able to care for their baby—there are so many economic burdens and impacts of untreated depression that you have to weigh,” she says.
The treatment, which Sage estimates will be available in June, doesn’t come cheap—the average cost per patient is $34,000, not including the stay at the clinic, according to The New York Times. Insurance coverage, which is currently being negotiated, will be vital to making sure women have access to Zulresso. “Our philosophy has really been about making sure there’s going to be access for patients,” says Mike Cloonan, Sage Pharmaceutical’s chief business officer. He says the company has been talking to more than 500 insurance providers for more than a year, raising awareness of postpartum depression and the issues facing women. “We feel very confident that we are going to have access for patients based on the feedback that we’ve received,” he says. Sage is also pledging to roll out a suite of tools to help patients navigate insurance, financial assistance, and where to go for the 60-hour infusions. “We’re trying to surround the patient with the support they’ll need throughout this process,” Cloonan says.
