Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, allowing it to be used as a standalone treatment for patients with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for individuals whose conditions did not improve after trying two or more antidepressants. Johnson & Johnson noted that approximately 30 percent of the 280 million people worldwide affected by major depressive disorder struggle with treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, indicated in a press release that many patients endure prolonged periods of ineffective treatment, resulting in significant emotional and functional challenges for both them and their families.
The company’s application included data from a late-stage clinical trial demonstrating that Spravato, when administered as a standalone treatment, was effective in alleviating symptoms as early as 24 hours post-treatment and maintained that relief for at least four weeks.
Spravato is delivered as a nasal spray and must be taken under the supervision of a healthcare professional in a clinical environment. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato functions by increasing levels of glutamate in the brain, which is essential for neuronal communication.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same timeframe in 2023. Johnson & Johnson reports that Spravato has been utilized by 100,000 patients across 77 countries.