The Food and Drug Administration approved the first drug developed specifically for postpartum depression, a debilitating condition that affects hundreds of thousands of women a year in the United States.
By Laurie McGinley and Laurie McGinley Reporter covering health and medicine Email Bio Follow Lenny Bernstein Lenny Bernstein Reporter covering health and medicine Email Bio Follow March 19 at 9:20 PM The Food and Drug Administration on Tuesday approved the first drug specifically for postpartum depression — a debilitating condition that affects hundreds of thousands of women a year in the United States.
Tiffany Farchione, acting director of the psychiatry products division at FDA, said in a statement that the medication represented “an important new treatment option” for a potentially life-threatening condition. The drug, she said, is administered intravenously for 60 continuous hours. The approval requires that it be administered under strict safety conditions because of concerns it can cause “excessive sedation and sudden loss of consciousness.
The FDA said the drug’s efficacy was shown in two clinical studies in which participants received either the medication or a placebo and were then followed for four weeks. “For women suffering, you can say, ‘You can come in and be treated and in 2.5 days it can go away, and not come back,’"she said. In clinical trials, she added, the IV administration did not prevent women from getting the drug.
The FDA’s advisory committee recommended approval of brexanolone in early November, but the agency delayed the green light to evaluate concerns about the small number of women who lost consciousness while receiving the drug. The agency’s safety requirements are designed to deal with those safety concerns.
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