STAT+: FDA approves Sage Therapeutics’ rapid-acting medication for postpartum depression but not major depression
The FDA on Friday approved Zurzuvae, a rapid-acting medicine from Sage Therapeutics to treat postpartum depression.
The Food and Drug Administration on Friday approved a new, rapid-acting medicine made by Sage Therapeutics to treat postpartum depression, the first oral treatment for the condition. But the agency denied the company’s application for an indication for major depression, a much larger potential market.
The drug, which will be sold under the brand name Zurzuvae, is not meant to be taken chronically. Patients take it orally for 14 days. In two clinical trials, the drug was found to significantly improve depressive symptoms more than a placebo. The effect was maintained for four weeks after treatment.
“Maternal mental health has been sidelined for far too long, but today’s approval of Zurzuvae helps to change that. Women have been waiting for an oral medicine that can specifically and rapidly improve the symptoms of PPD and we are proud to be able to deliver that,” said Barry Greene, Sage’s CEO, in a press release.
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