Johnson & Johnson announced on Monday that it has submitted a request 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 received its initial FDA approval in 2019 for use alongside an oral antidepressant for patients whose depression did not improve after trying two or more antidepressants. Currently, nearly 30 percent of the estimated 280 million individuals worldwide affected by major depressive disorder experience treatment-resistant depression, as noted by Johnson & Johnson.
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 create a significant functional and emotional burden on patients and their loved ones.”
The application to the FDA includes data from a late-stage clinical trial indicating that Spravato, when used alone, began alleviating symptoms within 24 hours of treatment and continued to provide relief for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a medical setting. Unlike typical antidepressants that target brain chemicals like serotonin and dopamine, Spravato functions by increasing the levels of glutamate, the brain’s most abundant neurotransmitter, which facilitates communication between neurons.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period last year. According to Johnson & Johnson, Spravato has been utilized by approximately 100,000 patients across 77 countries.