Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based drug, Spravato, as a standalone treatment for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in combination with an oral antidepressant for patients who did not respond to two or more other antidepressants. According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people globally suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, highlighted the struggles faced by patients with difficult-to-treat depression, stating that many spend excessive amounts of time cycling through ineffective treatments, which can impose significant emotional and functional strains on both patients and their families.
The application for the standalone use of Spravato was supported by data from a late-stage clinical trial showing that the drug effectively alleviated patients’ symptoms as early as 24 hours after treatment and maintained improvements for at least four weeks.
Spravato is administered via nasal spray and is required to be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that alter the levels of serotonin and dopamine in the brain, Spravato enhances the activity of glutamate, the most plentiful neurotransmitter, facilitating communication between neurons.
Sales of Spravato surged 60% to reach $271 million in the three months ending June 30, compared to the same period in 2023. Johnson & Johnson reported that the drug has been utilized by 100,000 individuals across 77 countries.