Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-derived medication, Spravato, as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant in patients whose symptoms failed to improve after two or more antidepressant therapies. According to Johnson & Johnson, approximately 30 percent of the 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 includes data from a late-stage clinical trial, which demonstrated that Spravato, when used as a standalone treatment, alleviated patient symptoms as early as 24 hours post-treatment, with effects lasting 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 target serotonin and dopamine levels, Spravato functions by enhancing glutamate activity in the brain, which is the most plentiful neurotransmitter and plays a key role in neuronal communication.
Sales of Spravato experienced a significant increase of 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2022. Spravato is currently being utilized by around 100,000 patients across 77 countries, according to Johnson & Johnson.