Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based medication, Spravato, as a standalone treatment for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 to be used in conjunction with an oral antidepressant for patients who did not see improvement after trying two or more antidepressants.
Johnson & Johnson reported that nearly 30 percent of the estimated 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression.
“Many patients dealing with difficult-to-treat depression spend too long cycling through various treatments that fail to alleviate their symptoms, which can create a significant emotional and functional burden for both them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application for expanded use was supported by data from a late-stage clinical trial, indicating that Spravato can reduce symptoms as quickly as 24 hours after administration and maintain effectiveness for at least four weeks.
Spravato is delivered via nasal spray and must be taken under the supervision of a healthcare provider in a medical setting. Unlike traditional antidepressants that adjust levels of serotonin and dopamine, Spravato functions by increasing glutamate levels in the brain, which is crucial for neuron communication.
Sales of Spravato surged by 60% to $271 million in the three months that ended on June 30, compared to the same period in 2022. The drug has been utilized by 100,000 patients across 77 countries, according to Johnson & Johnson.