Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) seeking to broaden the approved use of its ketamine-based medication, Spravato, as a standalone treatment for those suffering from treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 to be used alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people worldwide living with major depressive disorder experience treatment-resistant depression.
“Many patients facing difficult-to-treat depression often endure long periods trying various treatments that do not effectively alleviate their symptoms, leading to significant emotional and functional challenges for both patients and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The submission of the application was supported by data from a late-stage clinical trial, which indicated that Spravato, when used as a standalone treatment, showed the potential to alleviate symptoms within 24 hours and maintained efficacy for at least four weeks.
Spravato is administered through a nasal spray and requires supervision by a healthcare provider in a clinical setting. Unlike traditional antidepressants that primarily target chemicals like serotonin and dopamine, Spravato enhances glutamate levels in the brain, facilitating communication among neurons, as glutamate is the brain’s most abundant neurotransmitter.
Sales of Spravato surged by 60% to reach $271 million for the quarter ending June 30, compared to the same period in 2022. Johnson & Johnson reports that the medication has been utilized by 100,000 individuals across 77 countries.