Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based drug, Spravato, as a standalone treatment for resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients whose symptoms failed to improve with two or more antidepressants. According to Johnson & Johnson, approximately 30 percent of the estimated 280 million individuals worldwide with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, remarked in a press release, “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 includes data from a late-stage clinical trial indicating that Spravato, used as a standalone treatment, can alleviate patients’ symptoms as soon as 24 hours after administration and continue to provide relief for a minimum of four weeks.
Administered as a nasal spray, Spravato must be taken under a healthcare provider’s supervision in a medical setting. Unlike traditional antidepressants that target serotonin and dopamine levels, Spravato enhances glutamate activity, the most prevalent neurotransmitter in the brain, which is vital for neuronal communication.
In terms of commercial performance, sales of Spravato surged by 60%, reaching $271 million for the three months ending June 30, compared to the same timeframe in 2023. The drug has been utilized by 100,000 patients across 77 countries, as reported by Johnson & Johnson.