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 therapy for treatment-resistant depression.
Spravato originally received FDA approval in 2019 for use alongside an oral antidepressant in patients whose symptoms did not improve after trying two or more antidepressants.
Johnson & Johnson highlighted that nearly 30 percent of the estimated 280 million people worldwide living with major depressive disorder suffer from treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release that many individuals dealing with difficult-to-treat depression often experience long delays cycling through various treatments that fail to alleviate their symptoms, creating significant emotional and functional challenges for both patients and their families.
The application was supported by data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone treatment, began to alleviate patient symptoms as soon as 24 hours after administration and continued to do so for at least four weeks.
Spravato is delivered as a nasal spray and administration must occur under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that adjust brain chemicals such as serotonin and dopamine, Spravato enhances levels of glutamate, the brain’s most plentiful neurotransmitter, aiding neuronal communication.
Sales for Spravato surged by 60%, reaching $271 million in the three months ending June 30, compared to the same period last year. The medication has been used by approximately 100,000 individuals across 77 countries, according to Johnson & Johnson.