Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based drug, Spravato, allowing it to be used as a standalone treatment for those with treatment-resistant depression.
Spravato was first approved by the FDA in 2019 for use alongside 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 approximately 280 million individuals worldwide 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 was accompanied by data from a late-stage clinical trial indicating that Spravato, as a standalone treatment, successfully alleviated patients’ symptoms as early as 24 hours after administration and maintained its effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that primarily influence the levels of neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter and is crucial for neuronal communication.
Sales of Spravato increased by 60%, reaching $271 million during the three months ending June 30, when compared to the same period last year. Johnson & Johnson reported that Spravato has been utilized by 100,000 patients across 77 countries.