Esketamine regulatory update

Johnson & Johnson’s Janssen Research & Development LLC unit said FDA granted breakthrough drug designation to esketamine to treat major depressive disorder (MDD) in patients assessed to be at imminent risk for suicide. The designation was based on the double-blind, U.S. Phase II PeRSEVERe trial in 68 patients. Janssen said it is planning a Phase III trial of the intranasal NMDA receptor antagonist in the indication, but declined to provide a timeline. ...