Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, as a standalone treatment for 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 different antidepressants.
The pharmaceutical company noted that approximately 30 percent of the estimated 280 million individuals worldwide diagnosed with major depressive disorder suffer from treatment-resistant depression.
“Patients battling difficult-to-treat depression often spend too long trying multiple treatments that fail to alleviate their symptoms, imposing a significant emotional and functional toll on them and their families,” remarked Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application was accompanied by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, can begin to alleviate patients’ symptoms as quickly as 24 hours after administration, and maintains its effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the oversight of a healthcare provider in a clinical environment. Unlike traditional antidepressants that primarily influence brain chemicals like serotonin and dopamine, Spravato enhances the activity of glutamate, which is the most prevalent neurotransmitter in the brain, facilitating communication between neurons.
In terms of financial performance, sales of Spravato surged by 60% to $271 million for the three months ending June 30, compared to the same period in 2023. According to Johnson & Johnson, Spravato has been utilized by 100,000 individuals across 77 countries.