Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based medication, Spravato, as a standalone treatment for patients with treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was intended to be used in conjunction with an oral antidepressant for individuals whose symptoms did not improve after trying two or more 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 difficulties faced by these patients, noting that they often spend significant time attempting various treatments that fail to alleviate their symptoms, leading to considerable emotional and functional challenges for both themselves and their families.
The application to the FDA was supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, could begin to alleviate patients’ symptoms as soon as 24 hours after administration and maintain that relief for at least four weeks.
Spravato is delivered via a nasal spray and must be administered under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that primarily affect serotonin and dopamine levels, Spravato functions by enhancing glutamate activity in the brain, which is the most prevalent neurotransmitter and plays a crucial role in neuron communication.
In recent financial reports, sales of Spravato surged by 60% to $271 million during the quarter ending June 30, compared to the same timeframe in 2023. The medication has been utilized by around 100,000 individuals across 77 countries, according to Johnson & Johnson.