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 drug, Spravato, to function as a standalone treatment for individuals with treatment-resistant depression.
The FDA initially approved Spravato in 2019 for use alongside an oral antidepressant in patients who had not seen improvement after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the 280 million people worldwide suffering from major depressive disorder deal with treatment-resistant depression.
“Many patients facing difficult-to-treat depression endure prolonged periods of trying multiple therapies that fail to alleviate their symptoms, leading to significant emotional and functional struggles for both them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The company’s application includes data from a late-stage clinical trial indicating that Spravato, when used as an independent treatment, can start to alleviate symptoms within 24 hours and continue to do so for at least four weeks.
Spravato is administered as a nasal spray and must be taken in the presence of a healthcare provider at a healthcare facility. Unlike other antidepressants that primarily modify levels of serotonin and dopamine, Spravato enhances glutamate activity in the brain, which is the most abundant neurotransmitter and plays a crucial role in neuronal communication.
Sales of Spravato surged 60% to $271 million in the quarter ending June 30, compared to the same period in the previous year. The drug has been utilized by approximately 100,000 individuals across 77 countries, as reported by Johnson & Johnson.