Written on: February 8, 2025 by SprayTM
Johnson & Johnson announced that the U.S. Food & Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for its Spravato nasal spray as a standalone therapy for adults living with treatment-resistant depression (TRD).
A ketamine-based drug, Spravato had 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. In July 2024, J&J filed an updated submission supported by data from a Phase 4 trial that evaluated the efficacy, safety and tolerability of Spravato administered as a monotherapy.
According to J&J, this treatment is the first and only monotherapy for adults living with major depressive disorder (MDD) who have had an inadequate response to at least two oral antidepressants.
“Spravato is now available as a standalone treatment, meaning patients may experience improvements in depressive symptoms as early as 24 hours and at 28 days—without the need for daily oral antidepressants,” said Bill Martin, Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine.
This approval, which was granted following FDA Priority Review, is supported by positive results from a randomized, double-blind, multicenter, placebo-controlled study in which Spravato alone showed a rapid and superior improvement in Montgomery-Asberg Depression Rating Scale (MADRS) total score vs. placebo. Spravato works by targeting glutamate, which is the most abundant excitatory neurotransmitter in the brain. (The mechanism by which esketamine exerts its antidepressant effect is unknown, according to J&J.)
