Johnson & Johnson announced on Monday that it has submitted a new application to the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based medication, Spravato, as a standalone treatment for individuals with treatment-resistant depression.
Spravato was first approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose condition did not respond to two or more other antidepressants. According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people worldwide affected by major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the plight of patients who often spend extended periods trying various treatments that fail to alleviate their symptoms, significantly impacting both their functional abilities and emotional well-being.
The recent application is backed by data from a late-stage clinical trial indicating that Spravato, when used alone, can alleviate symptoms within 24 hours of treatment and maintain that relief for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that target serotonin and dopamine levels, Spravato operates by increasing glutamate in the brain, the most prevalent neurotransmitter, which facilitates communication between neurons.
Sales of Spravato have surged by 60%, reaching $271 million in the three-month period ending June 30, compared to the same timeframe in 2023. The medication has been utilized by 100,000 patients across 77 countries, as reported by Johnson & Johnson.