Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to extend the approved use of its ketamine-based drug, Spravato, as a standalone treatment for patients with treatment-resistant depression.
Spravato received its initial FDA approval in 2019, but only for use in conjunction with an oral antidepressant for individuals whose symptoms did not improve after trying two or more antidepressants.
Approximately 30 percent of the estimated 280 million people worldwide suffering from major depressive disorder are affected by treatment-resistant depression, according to Johnson & Johnson.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release, “Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones.”
The application for expanded use was supported by data from a late-stage clinical trial indicating that Spravato, as a standalone treatment, began alleviating symptoms in patients as soon as 24 hours after administration and continued to be effective for at least four weeks.
Spravato is delivered as a nasal spray and must be used under the supervision of a healthcare provider in a medical facility. Unlike traditional antidepressants that primarily adjust brain chemicals like serotonin and dopamine, Spravato enhances the action of glutamate, the brain’s most prevalent neurotransmitter, which is vital for neuronal communication.
Sales for Spravato surged by 60%, reaching $271 million in the second quarter of 2023, compared to the same period last year. According to Johnson & Johnson, the drug has been administered to 100,000 patients across 77 countries.