Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to extend the usage of its ketamine-based medication, Spravato, to be used as a standalone treatment for resistant depression.
Originally approved by the FDA in 2019, Spravato was intended for use in conjunction with an oral antidepressant for patients whose symptoms failed to improve with at least two other antidepressants.
Johnson & Johnson reported that nearly 30 percent of the approximately 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 is supported by data from a late-stage clinical trial indicating that Spravato can alleviate symptoms in patients as soon as 24 hours after treatment and maintain 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 environment. Unlike traditional antidepressants that focus on regulating serotonin and dopamine levels, Spravato enhances glutamate levels in the brain, which is essential for communication between neurons.
Sales of Spravato surged by 60%, reaching $271 million for the quarter ending June 30, compared to the same timeframe in 2022. The medication has been used by 100,000 individuals across 77 countries, according to Johnson & Johnson.