WASHINGTON DC - The US Food and Drug Administration on Friday approved for the first time a pill to treat postpartum depression, a condition believed to affect around half a million women in the country every year.
The antidepressant drug, called zuranolone, is "the first oral medication indicated to treat postpartum depression (PPD) in adults," the FDA said in a statement.
"Until now, treatment for PPD was only available as an IV injection given by a health care provider in certain health care facilities," it added.
Dr Asima Ahmad, the chief medical officer at Carrot Fertility, a healthcare company in Menlo Park, California, said that "about one in eight women experience PPD symptoms after a recent live birth, and among those reporting symptoms, 75 percent go untreated."
"These numbers are elevated for minority populations; 81 percent of Black women and 76 percent of Hispanic women said they would have liked to learn more about postpartum mental health before having children, compared to 70 percent of women overall," she said.
"In a time when we are seeing rising maternal mortality rates, and significant racial disparities in maternal outcomes, we need to focus on solutions, and that includes addressing postpartum depression."
The pill, specifically designed for postpartum depression, has been shown to work faster than other antidepressants and is designed to be taken only over a short two-week period.
Trials of the pill showed its side effects were less severe than other antidepressants currently in use, which can lead to sudden loss of consciousness, weight gain or sexual dysfunction, Ahmad said.
"Both the lower incidence of side effects and the short-term regimen, which could help some feel less stigma around having to use an antidepressant, could potentially improve compliance," she said.
Tiffany Farchione, head of psychiatry in the FDA's Center for Drug Evaluation and Research, said postpartum depression is "a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness -- even, in severe cases, thoughts of harming themselves or their child."
"Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings," she said.
The pill will be marketed under the brand name Zurzuvae, and was developed by Massachusetts-based Sage Therapeutics.
According to the New York Times, the only other drug approved for postpartum depression is brexanolone, which was approved by the FDA in 2019 but requires a 60-hour intravenous infusion in a hospital, and costs $34,000.
No price has yet been announced for the new oral pill.
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