Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based drug, Spravato, for treatment-resistant depression as a standalone therapy.
Spravato was first approved by the FDA in 2019 for use alongside an oral antidepressant for patients whose symptoms remained unaddressed after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the 280 million individuals globally diagnosed with major depressive disorder are affected by 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 to the FDA includes data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone treatment, can alleviate patients’ symptoms as early as 24 hours after administration and continues to be effective for at least four weeks.
Spravato is delivered as a nasal spray and must be used in a healthcare setting under the supervision of a healthcare provider. Unlike traditional antidepressants, which typically influence chemicals such as serotonin and dopamine, Spravato operates by enhancing glutamate levels in the brain, 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. The drug has been utilized by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.