Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based medication, Spravato, to function as a standalone treatment for individuals with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designed to be used alongside an oral antidepressant for patients whose conditions did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals globally living with major depressive disorder suffer from treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, expressed in a press release that many patients struggling with difficult-to-treat depression often endure prolonged periods of ineffective treatments, which can impose considerable emotional and functional strain on both the patients and their families.
The application to the FDA was supported by findings from a late-stage clinical study that indicated Spravato, when used alone, alleviated patients’ symptoms as early as 24 hours after administration, maintaining effectiveness for at least four weeks of treatment.
Spravato is delivered via nasal spray and must be administered under the guidance of a healthcare professional in a clinical environment. Unlike traditional antidepressants that influence chemicals such as serotonin and dopamine in the brain, Spravato enhances the activity of glutamate, the most prevalent neurotransmitter, facilitating communication between neurons.
Sales of Spravato surged by 60%, reaching $271 million for the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson reports that the medication has been utilized by 100,000 patients across 77 countries.