Johnson & Johnson (J&J, NYSE: JNJ), a leading global healthcare company, is pursuing expanded approval for its anti-depression drug Spravato (esketamine) in the U.S. by submitting a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA). The application seeks to establish Spravato CIII nasal spray as a monotherapy for adults living with treatment-resistant depression (TRD). This would add to the drug’s two existing indications, which both require its use in conjunction with an oral antidepressant, for treating adults with TRD and for depressive symptoms in adults with major depressive disorder (MDD) who are experiencing acute suicidal ideation or behavior, with approvals granted in 2020 and 2019, respectively.
Spravato, if approved, would stand as the sole monotherapy proven effective for TRD, a condition impacting nearly 30% of the estimated 280 million individuals worldwide with MDD. TRD is characterized by an insufficient response to two or more oral antidepressants during the same depressive episode. The sNDA filing is supported by the Phase IV TRD4005 study, a randomized, double-blind, multicenter, placebo-controlled trial that demonstrated a rapid change in the Montgomery-Asberg Depression Rating Scale (MADRS) total score within 24 hours of the first Spravato dose, with effects maintained for at least four weeks of treatment.- Flcube.com
