Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approval of its ketamine-based medication, Spravato, to allow it to be used as a standalone treatment for patients with treatment-resistant depression.
Spravato was first approved by the FDA in 2019 for use alongside an oral antidepressant for those whose symptoms did not improve after trying two or more other antidepressants. According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide with major depressive disorder experience treatment-resistant depression.
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 includes findings from a late-stage clinical trial that indicated Spravato, when used as a standalone therapy, could alleviate patients’ symptoms as soon as 24 hours after administration and remain effective for at least four weeks.
Spravato is delivered via nasal spray and must be administered under the supervision of a healthcare professional in a medical setting. Unlike traditional antidepressants that modify the brain’s serotonin and dopamine levels, Spravato increases glutamate activity in the brain, a key neurotransmitter that facilitates communication between neurons.
Sales of Spravato surged by 60% to $271 million for the quarter ending on June 30, compared to the same timeframe in the previous year. Johnson & Johnson reported that the medication has been prescribed to 100,000 patients across 77 countries.