Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to widen the approved use 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 other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide affected by major depressive disorder have treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated that many patients endure prolonged periods of trying various treatments without finding relief, which poses significant emotional and functional challenges for them and their families.
The application to the FDA includes data from a late-stage clinical trial demonstrating that Spravato, when used alone, can alleviate symptoms as soon as 24 hours after treatment and maintain effectiveness for at least four weeks.
Spravato is administered via nasal spray and must be taken under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that work by modulating brain chemicals like serotonin and dopamine, Spravato enhances glutamate activity in the brain, which is the most prevalent neurotransmitter and plays a crucial role in neuronal communication.
Sales for Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same timeframe in 2022. Johnson & Johnson reported that the medication has been utilized by 100,000 patients across 77 countries.