Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to seek approval for its ketamine-based drug, Spravato, as a standalone treatment for individuals with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designed to be used in conjunction with an oral antidepressant for patients who did not find relief from two or more antidepressants. Johnson & Johnson highlighted that nearly 30 percent of the estimated 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated, “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 company submitted the application supported by data from a late-stage clinical trial demonstrating that Spravato as a standalone treatment alleviated symptoms in patients as early as 24 hours after administration and maintained effectiveness for at least four weeks.
Spravato is delivered via nasal spray and must be administered under the supervision of a healthcare provider in a medical setting. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato enhances the effects of glutamate, the most abundant neurotransmitter, facilitating communication between neurons.
Sales of Spravato surged by 60%, reaching $271 million for the quarter ending June 30, compared to the same timeframe in 2023. To date, Spravato has been utilized by approximately 100,000 individuals across 77 countries.