Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based treatment, Spravato, as a standalone therapy for individuals with treatment-resistant depression.
Initially approved in 2019, Spravato was designed to be used in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressant medications. Johnson & Johnson highlighted that nearly 30 percent of the approximately 280 million people globally who suffer from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release, “Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones.”
The application for the expanded use of Spravato includes data from a late-stage clinical trial, demonstrating that the drug, when used as a standalone treatment, can alleviate symptoms as soon as 24 hours after administration and maintain efficacy for at least four weeks.
Spravato is delivered through a nasal spray and must be administered under healthcare supervision. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato enhances the action of glutamate, the brain’s most abundant neurotransmitter, facilitating better communication between neurons.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in 2022. According to Johnson & Johnson, the drug has been prescribed to 100,000 patients across 77 countries.