Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) for the expanded use of its ketamine-based drug, Spravato, as a standalone treatment for treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was designed to be used alongside an oral antidepressant for patients who did not respond to two or more prior treatments. According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals 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 application is supported by data from a late-stage clinical trial, which indicated that Spravato, when used as a solo treatment, could alleviate patient symptoms within 24 hours and maintain effectiveness for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that typically target chemicals like serotonin and dopamine, Spravato enhances glutamate levels in the brain, facilitating communication between neurons.
Sales for Spravato surged by 60%, reaching $271 million in the three months ending June 30, compared to the same period last year. Spravato has been utilized by approximately 100,000 individuals in 77 countries, according to Johnson & Johnson.