Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based drug, Spravato, as a standalone treatment for treatment-resistant depression.
Spravato was first approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose conditions did not improve after trying two or more antidepressants. According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated, “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 expanded use was supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone therapy, alleviated symptoms within 24 hours and sustained improvement for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that affect brain chemicals like serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter and facilitates communication between neurons.
Sales for Spravato surged by 60%, reaching $271 million in the three months ending June 30, compared to the same timeframe in 2023. The drug has been utilized by 100,000 patients across 77 countries, according to Johnson & Johnson.