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.
Zurzuvae’s prescription label carries a boxed warning, the FDA’s strongest caution, noting that the drug can cause impairment due to sedative effects. People taking Zurzuvae are cautioned not to drive or engage in other potentially hazardous activities until at least 12 hours after dosing during the two-week treatment course.