Written on: July 28, 2024 by SprayTM
Johnson & Johnson has submitted a supplemental New Drug Application (sNDA) to the U.S. Food & Drug Administration (FDA) seeking approval of its Spravato nasal spray as a standalone therapy for adults living with treatment-resistant depression (TRD).
A ketamine-based drug, Spravato has already been approved by the FDA to be used in conjunction with an oral antidepressant by adults with TRD, which occurs when there is an inadequate response to two or more oral antidepressants during the same depressive episode.
The updated submission is supported by data from a Phase 4 trial that evaluated the efficacy, safety and tolerability of Spravato administered as a monotherapy.
The randomized, double-blind, multicenter, placebo-controlled study showed that depression symptoms eased as early as 24 hours after the first Spravato dose and lasted through at least four weeks of treatment. The safety profile of Spravato monotherapy was consistent with the existing body of clinical data in combination with an oral antidepressant, and no new safety concerns were identified, according to J&J.
