Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) seeking approval to use its ketamine-based drug, Spravato, as a standalone treatment for 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 find relief from two or more traditional antidepressants. According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people globally dealing with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the burden faced by patients who struggle to find effective treatments. He noted that many endure prolonged periods trying various therapies without success, which adds a significant emotional and functional toll on them and their families.
The application to the FDA is backed by results from a late-stage clinical trial demonstrating that Spravato, when used alone, can alleviate symptoms as soon as 24 hours post-treatment and maintain effectiveness for at least four weeks.
Spravato is administered as a nasal spray and must be used under the oversight of a healthcare professional in a clinical setting. Unlike typical antidepressants that target brain chemicals like serotonin and dopamine, Spravato acts by increasing levels of glutamate, the brain’s most abundant neurotransmitter, which plays a crucial role in neuronal communication.
Sales of Spravato saw a significant increase, soaring 60% to $271 million for the quarter ending June 30, compared to the same time last year. Johnson & Johnson reports that Spravato has been used by 100,000 individuals in 77 countries worldwide.