by Nola Family Staff, March 20,2019
For the first time, a drug has been given FDA approval to help thousands of women who battle postpartum depression.
On Tuesday, the FDA announced the approval of an intravenous infusion of the drug brexanolone, which will be sold as Zulresso, a product of Sage Therapeutics, Inc. It has been shown in clinical trials to work within hours to treat the symptoms of postpartum depression, a serious mental illness that impacts 1 in 9 new mothers after childbirth.
“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. This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option,” said Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research announced in a press release on Tuesday.
“Because of concerns about serious risks, including excessive sedation or sudden loss of consciousness during administration, Zulresso has been approved with a Risk Evaluation and Mitigation Strategy (REMS) and is only available to patients through a restricted distribution program at certified health care facilities where the health care provider can carefully monitor the patient.”