Johnson & Johnson announced on Monday that it has filed an application with 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 received FDA approval in 2019, but it was only authorized for use in conjunction with an oral antidepressant for patients whose symptoms failed to improve after trying two or more antidepressants.
The company highlighted that nearly 30 percent of the estimated 280 million individuals worldwide experiencing major depressive disorder suffer from treatment-resistant depression. Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release that many patients endure lengthy periods cycling through various treatments that do not alleviate their symptoms, which can impose significant emotional and functional challenges.
The application for expanded use was supported by data from a late-stage clinical trial, which demonstrated that Spravato, when administered alone, was effective in alleviating symptoms as soon as 24 hours after treatment and maintained effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be administered in a healthcare setting under the supervision of a qualified provider. Unlike traditional antidepressants that focus on regulating serotonin and dopamine levels, Spravato enhances the activity of glutamate in the brain, the most prevalent neurotransmitter that facilitates communication between neurons.
Sales of Spravato surged by 60%, reaching $271 million in the three-month period ending June 30, compared to the same timeframe in 2023. According to Johnson & Johnson, the medication has already been utilized by 100,000 patients across 77 countries.