Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved usage of its ketamine-based medication, Spravato, allowing it to be used as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the 280 million people globally with major depressive disorder are affected by treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release, “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 submission to the FDA included data from a late-stage clinical trial indicating that Spravato, when used as a standalone therapy, was effective in alleviating patients’ symptoms as early as 24 hours after treatment and continued to show benefits for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that influence brain chemicals like serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most abundant neurotransmitter and aids in neuronal communication.
Sales of Spravato increased by 60%, reaching $271 million in the quarter ending June 30, compared to the same timeframe in 2023. To date, approximately 100,000 individuals in 77 countries have used Spravato, as reported by Johnson & Johnson.