Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the approval of its ketamine-based drug, Spravato, for use as a standalone treatment for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019, but only for use in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants. Johnson & Johnson highlighted that nearly 30 percent of the 280 million people globally suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients with hard-to-treat depression, noting that they often spend considerable time attempting multiple treatments that ultimately fail to alleviate their symptoms, resulting in significant emotional and functional strain on them and their families.
The FDA application includes data from a late-stage clinical trial demonstrating that Spravato, when used independently, relieved patient symptoms as early as 24 hours after treatment and remained effective for at least four weeks.
Administered as a nasal spray, Spravato must be given under the supervision of a healthcare provider in a clinical environment. Unlike traditional antidepressants that adjust levels of serotonin and dopamine in the brain, Spravato enhances glutamate, the brain’s most prevalent neurotransmitter, facilitating communication between neurons.
In the second quarter of 2023, sales of Spravato surged by 60% to reach $271 million compared to the same timeframe last year. According to Johnson & Johnson, Spravato has been used by approximately 100,000 individuals across 77 countries.