Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based drug, Spravato, allowing it to be used as a standalone therapy for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was permitted for use in conjunction with an oral antidepressant for patients whose symptoms failed to improve after trying two or more antidepressants.
Johnson & Johnson highlighted that nearly 30 percent of the estimated 280 million individuals globally suffering from 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 to the FDA includes data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, can alleviate patients’ symptoms as quickly as 24 hours after administration and maintains effectiveness for at least four weeks.
Spravato is administered as a nasal spray and is required to be taken under the supervision of a healthcare provider in a medical setting. Unlike traditional antidepressants that primarily act on neurotransmitters such as serotonin and dopamine, Spravato enhances the function of glutamate in the brain, a key neurotransmitter that facilitates communication between neurons.
Commercially, Spravato saw a significant surge, with sales rising by 60% to $271 million during the quarter ending June 30, when compared to the same timeframe in 2023. The drug has been utilized by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.