The U.S. Food and Drug Administration (FDA) on Friday approved Zurzuvae as the first oral treatment for postpartum depression (PPD).
The approval comes after the efficacy of Zurzuvae, from Sage Therapeutics, Inc., was shown in two randomized, double-blind, placebo-controlled, multi-center studies of women with PPD who showed significant improvement in their symptoms after two weeks of treatment and continuing for four weeks after the final dose, the FDA said.
Positive affects were seen as soon as three days, much faster than other depression treatments, which can take one or two months, Dr. Jamille Nagtalon-Ramos, an Assistant Professor of Nursing at Rutgers University in New Jersey and member of Women’s Healthcare, A Clinical Journal for NPs‘ Editorial Advisory Board, said in an interview on National Public Radio’s Morning Edition.
Nagtalon-Ramos said she is hopeful for the new 14-day treatment, although she’d like to see long-term benefits beyond the studies’ 45-day analysis. She said she is also eager to learn the cost for the new treatment.
Sage Therapeutics’ Zurlesso was approved in 2019 for treatment of PPD but it is administered intravenously and can cost as much as $30,000. A price for Zurzuvae, which Sage said it expects to be available later this year, has not been announced, but its potential benefit is indicated by FDA having designating it a Priority Review and Fast Track application.
“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,” said Tiffany R. Farchione, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research. “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”