Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to extend the use of its ketamine-derived drug, 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 alongside oral antidepressants for patients whose symptoms remained unresolved after trying two or more antidepressants. According to Johnson & Johnson, almost 30 percent of the approximately 280 million people worldwide with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated that many individuals suffering from difficult-to-treat depression often endure prolonged periods trying multiple therapies that fail to alleviate their symptoms, leading to significant emotional and functional challenges for both patients and their families.
The application to the FDA was supported by data from a late-stage clinical trial showing that Spravato, when used alone, could begin to alleviate symptoms as soon as 24 hours after treatment and continue to provide relief for at least four weeks.
Spravato is administered as a nasal spray and must be used under the supervision of a healthcare professional in a clinical environment. Unlike traditional antidepressants that typically affect neurotransmitters such as serotonin and dopamine, Spravato enhances the activity of glutamate in the brain, which is the most prevalent neurotransmitter and plays a crucial role in neuronal communication.
In financial terms, Spravato’s sales increased by 60% to $271 million in the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson reported that Spravato has been utilized by approximately 100,000 patients across 77 countries.