Janssen Submits Application To FDA For SPRAVATO® CIII Nasal Spray For Adults With MDD

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental New Drug Application  to the U.S. Food and Drug Administration (FDA) seeking a new indication for SPRAVATO® (esketamine) CIII nasal spray for the rapid reduction of depressive symptoms in adult consumers with major depressive disorder (MDD) who have active suicidal ideation with intent. The submission is based on results from the Phase 3 ASPIRE I & II trials, which evaluated the efficacy and safety of SPRAVATO® versus placebo nasal spray in this high-risk population when used in addition to comprehensive standard of care (SOC . . .