Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to allow its ketamine-based drug, Spravato, to be used as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 as a supplemental therapy to be used alongside an oral antidepressant for patients whose depression did not improve after taking two or more other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, expressed concern for those facing difficult-to-treat depression. He noted that many patients often go through numerous treatments that fail to alleviate their symptoms, leading to significant emotional and functional challenges for both them and their families.
The application to the FDA includes findings from a late-stage clinical trial demonstrating that Spravato, when used alone, can help alleviate symptoms as soon as 24 hours after administration and sustain improvements for at least four weeks.
Spravato is delivered via nasal spray and must be administered under the guidance of a healthcare professional in a clinical setting. Unlike traditional antidepressants that affect serotonin and dopamine levels in the brain, Spravato enhances glutamate activity, which is the most prevalent neurotransmitter and facilitates communication between neurons.
Sales of Spravato surged by 60% to reach $271 million in the second quarter of this year compared to the same timeframe in 2022. The drug has been utilized by approximately 100,000 individuals across 77 countries, as reported by Johnson & Johnson.