Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) seeking to expand the approved use of its ketamine-based medication, Spravato, 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 estimated 280 million individuals worldwide suffering from major depressive disorder endure treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients with difficult-to-treat depression, stating that many spend excessive time trying various treatments that fail to alleviate their symptoms, leading to significant emotional and functional difficulties for both them and their families.
The application includes findings from a late-stage clinical study demonstrating that Spravato, when used alone, can alleviate symptoms in patients as quickly as 24 hours after administration and continue to be effective for at least four weeks.
Spravato is administered as a nasal spray and requires supervision from a healthcare provider in a clinical environment. Unlike traditional antidepressants that affect brain chemicals such as serotonin and dopamine, Spravato operates by enhancing glutamate levels in the brain, which is the most prevalent neurotransmitter that facilitates communication between neurons.
In the three-month period ending June 30, sales of Spravato surged by 60% to $271 million compared to the same timeframe in 2022. Johnson & Johnson reports that the medication has been utilized by 100,000 individuals across 77 countries.