Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the approved use of its ketamine-based drug, Spravato, as a standalone therapy for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was intended to be used in conjunction with an oral antidepressant for patients whose symptoms remained unchanged despite trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people globally who have major depressive disorder suffer from 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 is supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, helps alleviate patient symptoms as soon as 24 hours after administration, with effects lasting at least four weeks.
Spravato is administered via nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that target chemicals such as serotonin and dopamine in the brain, Spravato increases levels of glutamate, the most prevalent neurotransmitter, which is essential for neuronal communication.
Sales of Spravato surged 60% to $271 million in the three months ending June 30, compared to the same period last year. Johnson & Johnson reports that the drug has been utilized by 100,000 individuals across 77 countries.