Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based medication, Spravato, to serve as a standalone treatment for individuals with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designed to be used alongside an oral antidepressant for patients who did not respond to two or more other antidepressants. According to Johnson & Johnson, an estimated 30 percent of the 280 million people 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 for standalone use was backed by data from a late-stage clinical trial that demonstrated Spravato’s ability to alleviate symptoms as quickly as 24 hours after administration and for at least four weeks following treatment.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a clinical setting. Unlike other antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato elevates levels of glutamate, the most abundant neurotransmitter in the brain that facilitates communication between neurons.
Sales for Spravato experienced a considerable increase of 60%, reaching $271 million for the three-month period ending June 30, compared to the same timeframe in 2023. The medication has been utilized by approximately 100,000 patients across 77 countries, according to Johnson & Johnson.