FDA approves first oral treatment for postpartum depression

In clinical trials, drug manufacturers Sage Therapeutics and Biogen said the zuranolone pill quickly reduced postpartum symptoms such as depression and other cognitive issues.

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The zuranolone pill, sold under the brand name Zurzuvae, was approved by the Food and Drug Administration (FDA) for postpartum depression. The oral treatment is expected to launch at the end of this year.

In clinical trials, drug manufacturers Sage Therapeutics and Biogen said the zuranolone pill quickly reduced postpartum symptoms such as depression and other cognitive issues.

“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. And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development,” Tiffany R. Farchione, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, said. “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”

While one in seven women in the U.S. experiences postpartum depression with symptoms ranging from sadness, suicidal thoughts, low energy and other cognitive issues, half of new mothers who are suffering remain undiagnosed, according to The National Library of Medicine. The zuranolone pill

While clinical trial data showed that the zuranolone pill “alleviates depression in as little as three days, faster than standard antidepressants,” many maternal mental health experts said the quick effects along with the short treatment duration “could encourage more patients to accept and seek treatment and help reduce stigma for women, Causes.com reported.

“This is a patient population that just so often falls through the cracks. When women are told, ‘You have postpartum depression,’ it’s embarrassing, it is demeaning, it makes them feel like a bad mom,” Dr. Ruta Nonacs, a psychiatrist at Massachusetts General Hospital, said.

The zuranolone pill is the first oral treatment approved by the FDA—prior to this pill, treatment for PPD was “only available as an IV injection given by a health care provider in certain health care facilities,” according to the FDA.

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