Panels Weigh Antidepressant That Used Randomized Withdrawal Trial

By Beth Wang
February 11, 2019 at 5:34 PM
Two FDA advisory panels on Tuesday (Feb. 12) will discuss the safety and efficacy of a novel esketamine drug-device combination intended to treat treatment-resistant depression (TRD), with the proposed treatment marking the first antidepressant product for which a randomized withdrawal trial was used to help show efficacy. Esketamine has not been FDA-approved for any indication but it has been approved as an anesthetic in Europe and South America, FDA explains in its briefing materials. The Institute for Clinical and Economic...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on the coming Democrat-controlled House of Representatives, drug pricing reforms, Medicaid policy, FDA news and much more.