Johnson & Johnson Seeks FDA Approval for SPRAVATO® Nasal Spray as Standalone Treatment for Depression
Johnson & Johnson has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the approval of SPRAVATO® (esketamine) CIII nasal spray as a monotherapy for adults with treatment-resistant depression (TRD). This condition affects about 30 percent of the estimated 280 million people worldwide living with major depressive disorder (MDD), characterized by an inadequate response to two or more oral antidepressants during the same depressive episode. Bill Martin, PhD, Global Therapeutic Area Head, Neuroscience at Johnson & Johnson Innovative Medicine, highlighted the significant burden TRD places on patients and their families due to prolonged periods of ineffective treatment. He expressed optimism about the potential of SPRAVATO® to offer a new monotherapy option based on extensive research demonstrating its safety and efficacy.
Johnson & Johnson Seeks FDA Approval for SPRAVATO® Nasal Spray as Standalone Treatment for Depression