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 medication, Spravato, to be utilized as a standalone treatment for treatment-resistant depression.
Initially approved by the FDA in 2019 for use alongside an oral antidepressant in patients whose symptoms failed to improve after two or more antidepressants, Spravato is now being considered for broader usage. Johnson & Johnson noted that 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 was supported by data from a late-stage clinical trial that indicated Spravato, as a standalone therapy, was effective in alleviating symptoms as quickly as 24 hours after treatment and maintained efficacy for at least four weeks.
Administered as a nasal spray, Spravato is required to be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato primarily enhances levels of glutamate in the brain, which is the most prevalent neurotransmitter and essential for neuronal communication.
Sales of Spravato increased by 60% to $271 million in the quarter ending June 30, compared to the same period in 2022. The medication has been utilized by approximately 100,000 individuals across 77 countries, according to Johnson & Johnson.