SALT LAKE CITY — The U.S. Food and Drug Administration announced Tuesday the approval of the first drug specifically designed to treat postpartum depression in new mothers.
The drug could save the lives of mothers and children, according to the FDA, but it's expensive, averaging $34,000 per patient before discounts, and requires a stay in a hospital, according to Sage Therapeutics, the drug's manufacturer.
Brexanolone, which will be marketed as Zulresso, is administered via intravenous infusion over 2½ days, according to the FDA's press release. It works within 48 hours, much faster than other antidepressants, the New York Times reported.
"This brings up a lot of very complex public health issues," Dr. Kimberly Yonkers, a professor of psychiatry, obstetrics, gynecology and preproductive sciences at Yale, told the New York Times. "It may be worth it if somebody has been treatment-resistant or they can't wait the two to four weeks for an antidepressant to kick in."
On social media, people expressed joy at the availability of treatment and dismay at the cost of the drug.
Sage Therapeutics told the Times that insurance companies are currently evaluating Zulresso, and the company expects insurers will cover the treatment. In addition, a pill with similar chemistry that would be much more accessible will be submitted for approval in a couple of years if testing continues to prove its effectiveness, Sage told the Times.
Each year more than 400,000 infants in the United States are born to mothers who are depressed, according to a 2017 study published in Pediatrics in Review. And the condition impacts 1 in 9 women nationally, according to the Centers for Disease Control and Prevention.
Postpartum depression often occurs following childbirth, but symptoms, including sadness, decreased ability to feel pleasure, cognitive impairment, feelings of worthlessness or suicidal ideation can start during pregnancy, says the FDA.
"Postpartum depression is a serious condition that, when severe, can be life-threatening. Women may experience thoughts about harming themselves or harming their child. Postpartum depression can also interfere with the maternal-infant bond," said Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research in the press release. "This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option."
Because of the drug's risks, including sudden loss of consciousness, Zulresso will only be available at certified health care facilities where patients can be carefully monitored, according to the press release.
Jeff Jonas, CEO of Sage Therapeutics, told CNN that the drug will be available in June.
Without treatment for postpartum depression, which typically involves counseling and traditional antidepressant medications, women can suffer for months or even years, according to the National Institute of Mental Health.
Researchers found Zulresso to be effective in two clinical studies where participants were given either the drug or a placebo and then followed for four weeks, according to the press release. One study focused on patients with severe postpartum depression and the other focused on patients with moderate postpartum depression. In both experiments, Zulresso was more effective than the placebo at reducing depressive symptoms, the press release said.
Zulresso specifically targets postpartum depression as opposed to other types of depression because it contains a synthetic form of the hormone allopregnanolone, NBC reported. The hormone increases throughout a woman’s pregnancy and plummets after she gives birth, potentially contributing to depressive symptoms.
Dr. Samantha Meltzer-Brody, professor of mood and anxiety disorders at the University of North Carolina School of Medicine in Chapel Hill, told NBC that the Zulresso is designed for postpartum depression but "is a step in understanding how we treat depression more broadly.”16 comments on this story
“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,” she said. Just a few weeks ago, the FDA approved esketamine, a fast-acting nasal spray, as a treatment for severe depression.
Meltzer-Brody, who was involved in trials for the Zulresso, said her greatest hope is that the drug's release will increase awareness about the serious suffering so many new mothers endure.
"What's heartbreaking is the number of women who suffer in silence and do not get the treatment that they need," she told CNN. "People need to reach out and get screened and get treatment, regardless of if treatment is with brexanolone or not."