Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based drug, Spravato, as a standalone treatment for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 as an adjunct to oral antidepressants for patients whose conditions did not improve after trying two or more such medications.
The company highlighted that nearly 30 percent of the approximately 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the significant burden that undiagnosed patients face, stating, “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 expanded approval was supported by data from a late-stage clinical trial indicating that Spravato as a standalone treatment could alleviate symptoms as early as 24 hours post-treatment, lasting for a minimum of four weeks.
Spravato is delivered as a nasal spray and must be administered under the oversight of a healthcare professional in a clinical setting. Unlike traditional antidepressants that influence serotonin and dopamine levels, Spravato enhances glutamate activity in the brain. Glutamate serves as the brain’s most abundant neurotransmitter and facilitates communication between neurons.
Sales of Spravato surged by 60% to reach $271 million in the quarter ending June 30, compared to the same period in 2022. To date, Spravato has been utilized by 100,000 patients across 77 countries.