Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based drug, Spravato, allowing it to be utilized as a standalone treatment for those with treatment-resistant depression.
Spravato initially received FDA approval in 2019 as an adjunct to an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants. According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide living 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 is supported by data from a late-stage clinical trial that indicated Spravato as a standalone treatment can alleviate symptoms as quickly as 24 hours after administration and sustain improvement for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a controlled setting. Unlike traditional antidepressants that primarily affect serotonin and dopamine levels, Spravato functions by increasing glutamate levels in the brain, enhancing neuronal communication.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same time in 2023. Johnson & Johnson reports that the drug has been utilized by 100,000 individuals across 77 countries.