Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based medication, Spravato, as a standalone treatment for individuals with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designed to be used in conjunction with an oral antidepressant for patients who did not find relief from two or more other antidepressants. According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people globally who suffer from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients with difficult-to-treat depression, stating that they often endure extended periods trying multiple treatments that fail to alleviate their symptoms, leading to considerable emotional and functional strain on both patients and their families.
The application to the FDA includes data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone treatment, was effective in reducing symptoms in patients as early as 24 hours after treatment and maintained this improvement for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a medical setting. Unlike traditional antidepressants that primarily target serotonin and dopamine levels, Spravato enhances the activity of glutamate in the brain, which is the most abundant neurotransmitter and plays a crucial role in neuronal communication.
In terms of financial performance, sales of Spravato surged by 60% to $271 million in the three months ending June 30, compared to the same quarter in 2022. The drug has been utilized by 100,000 patients across 77 countries, as reported by Johnson & Johnson.