Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based drug, Spravato, for treating resistant depression as a standalone therapy.
Originally approved by the FDA in 2019, Spravato was intended for use alongside an oral antidepressant for patients whose conditions did not improve after trying two or more antidepressants.
The company highlighted that nearly 30 percent of the approximately 280 million individuals worldwide with major depressive disorder experience treatment-resistant depression. Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the struggles many patients face while navigating ineffective treatments, which can impose significant emotional and functional burdens on them and their families.
The application was supported by data from a late-stage clinical trial indicating that Spravato, when used alone, could alleviate symptoms within 24 hours of treatment and maintain those improvements for at least four weeks.
Spravato is administered via a nasal spray under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that affect serotonin and dopamine levels, Spravato operates by enhancing glutamate activity in the brain, which is vital for neuronal communication.
Sales for Spravato surged by 60% to $271 million during the three months ending June 30, compared to the same time frame in the previous year. Johnson & Johnson also reported that the drug has been used by 100,000 patients across 77 countries.