Last for one month! Johnson & Johnson (JNJ.US) submits new marketing application for anti-inflammatory nasal spray
On July 22, 2021, Johnson & Johnson (JNJ.US) announced that it had submitted a supplemental New Drug Application (sNDA) to the U.S. FDA to seek approval for Spravato (esketamine, clobenzapam) nasal spray as a single agent treatment for adults with treatment-resistant depression (TRD). The application was supported by positive results from the Phase IV TRD4005 clinical trial.
The TRD4005 trial was a randomized, double-blind, multicenter, placebo-controlled trial that evaluated the efficacy, safety, and tolerability of Spravato as a single agent in the treatment of patients with TRD. The results showed a rapid change in the total score of the Montgomery-Asberg Depression Rating Scale (MADRS) within 24 hours of the first use of Spravato and at least 4 weeks thereafter. The safety of Spravato as a single agent was consistent with existing clinical data from trials of Spravato in combination with oral antidepressants, and no new safety concerns were identified.
Publicly available information indicates that Spravato is an N-methyl-D-aspartate (NMDA) receptor antagonist that results in presynaptic disinhibition, increasing the release of presynaptic GABA. This in turn activates downstream neurotrophic signaling pathways within the neuron, leading to increased synaptic protein synthesis, synaptic transmission, and ultimately improved synaptic connectivity. Spravato has been approved by the FDA for use in combination with oral antidepressants for the treatment of adults with TRD and for the treatment of symptoms of major depression in adults with severe depression, particularly those with acute suicidal ideation or behavior. Spravato has been approved in 77 countries.