Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based medication, Spravato, for treatment-resistant depression as a standalone therapy.
Spravato was initially approved by the FDA in 2019, but only for use in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants. Johnson & Johnson highlighted that approximately 30 percent of the 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release that many patients with difficult-to-treat depression often endure lengthy periods of trying multiple treatments that fail to alleviate their symptoms, which can lead to significant emotional and functional burdens for both patients and their families.
The application for the expanded use of Spravato includes data from a late-stage clinical trial indicating that, when used as a standalone treatment, it helped reduce symptoms as soon as 24 hours after administration and maintained effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that modify levels of serotonin and dopamine in the brain, Spravato enhances glutamate activity. Glutamate is the brain’s most prevalent neurotransmitter and plays a crucial role in neuronal communication.
Sales of Spravato surged by 60%, amounting to $271 million for the quarter ending June 30, compared to the same period last year. Johnson & Johnson reports that Spravato has been utilized by 100,000 individuals across 77 countries.