Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based medication, Spravato. The company seeks to make it available as a standalone treatment option for individuals with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was restricted to use alongside an oral antidepressant for patients who did not respond to two or more antidepressant therapies. Johnson & Johnson highlighted that nearly 30% of the approximately 280 million people globally who suffer from major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, stated, “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 latest application includes findings from a late-stage clinical trial that indicated Spravato could alleviate symptoms as quickly as 24 hours after administration and provide relief 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 clinical setting. Unlike traditional antidepressants that typically affect serotonin and dopamine levels, Spravato enhances glutamate activity in the brain, which is crucial for neuronal communication.
Sales of Spravato surged by 60% to $271 million for the three months ending June 30, 2023, compared to the same period in the previous year. The medication has been utilized by around 100,000 patients in 77 countries, according to Johnson & Johnson.