Johnson & Johnson announced on Monday that it has filed a request with the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based medication, Spravato, as a standalone treatment for individuals suffering from treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designated for use in conjunction with an oral antidepressant for patients who did not respond to two or more antidepressant therapies.
According to Johnson & Johnson, around 30 percent of the approximately 280 million individuals globally living with major depressive disorder experience treatment-resistant depression.
Bill Martin, the 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 submission to the FDA is supported by data from a late-stage clinical trial, which indicated that Spravato, when used as a standalone treatment, could alleviate patients’ symptoms as quickly as 24 hours after administration and maintain effectiveness for at least four weeks.
Spravato is delivered via nasal spray and is required to be taken under the supervision of a healthcare professional in a medical setting. Unlike traditional antidepressants that target serotonin and dopamine levels, Spravato functions by enhancing glutamate activity in the brain. Glutamate is the most prevalent neurotransmitter in the brain and facilitates communication between neurons.
Sales for Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same timeframe in 2023. Johnson & Johnson reports that Spravato has been administered to 100,000 individuals across 77 countries.