Phase 4 SPRAVATO® monotherapy data shows rapid improvement in depressive symptoms at ~24 hours, sustained through at least 4 weeks
Monotherapy submission builds on more than a decade of research, 31 clinical trials and more than five years of real-world use that reinforce the safety and efficacy of SPRAVATO®
TITUSVILLE, N.J., July 22, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of SPRAVATO® (esketamine) CIII nasal spray as a monotherapy for adults living with treatment-resistant depression (TRD). Nearly 30 percent of the estimated 280 million people worldwide living with major depressive disorder (MDD) have TRD,1 which occurs when there is an inadequate response to two or more oral antidepressants during the same depressive episode.
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