Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) seeking to expand the approved use of its ketamine-based medication, Spravato, to serve as a standalone treatment for individuals suffering from treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients whose condition did not improve with at least two different antidepressant medications.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide affected by major depressive disorder experience treatment-resistant depression.
“Many patients struggling with hard-to-treat depression endure lengthy periods trying various treatments without relief, which can take a considerable emotional and functional toll on both them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application to the FDA is supported by data from a late-stage clinical trial that indicated Spravato, when used alone, could alleviate symptoms as quickly as 24 hours post-treatment and maintain effectiveness for at least four weeks.
Spravato is administered via a nasal spray and must be given under the supervision of a healthcare professional in a clinical environment. Unlike traditional antidepressants that typically target serotonin and dopamine levels, Spravato enhances glutamate activity in the brain. Glutamate is the most prevalent neurotransmitter and plays a crucial role in neuronal communication.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same timeframe in 2023. The medication has been utilized by approximately 100,000 patients across 77 countries, as reported by Johnson & Johnson.