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 treatment-resistant depression.
Spravato was initially approved by the FDA in 2019, but only for use in combination with an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants. Approximately 30% of the estimated 280 million individuals worldwide with major depressive disorder suffer from treatment-resistant depression, according to Johnson & Johnson.
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 was supported by data from a late-stage clinical trial demonstrating that Spravato helps alleviate patients’ symptoms as soon as 24 hours after treatment, continuing for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that affect serotonin and dopamine levels, Spravato enhances glutamate activity in the brain, which is the most prevalent neurotransmitter and facilitates communication between neurons.
Sales of Spravato surged by 60% to $271 million for the three months ending June 30, compared to the same period in 2023. The drug has been utilized by 100,000 patients across 77 countries, according to Johnson & Johnson.