Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the approved usage of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone treatment for individuals with treatment-resistant depression.
Initially approved in 2019, Spravato was designed to be used in conjunction with an oral antidepressant for patients who did not achieve improvement after trying two or more different antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximate 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 FDA application includes data from a late-stage clinical trial that demonstrated Spravato as a standalone therapy was effective in alleviating patients’ symptoms within 24 hours of treatment and maintained that relief for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike other antidepressants that primarily influence neurotransmitters such as serotonin and dopamine, Spravato operates by enhancing levels of glutamate, the brain’s most abundant neurotransmitter, facilitating communication between neurons.
Sales of Spravato surged by 60% to reach $271 million in the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson reports that the medication has been utilized by 100,000 individuals across 77 countries.