Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) seeking to expand the approved use of its ketamine-based drug, Spravato, for use as a standalone therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 to be administered alongside an oral antidepressant for patients whose conditions did not improve after trying two or more antidepressants. Johnson & Johnson highlighted that nearly 30 percent of the estimated 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated 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 to the FDA was supported by results from a late-stage clinical trial, which indicated that Spravato, when used as a standalone treatment, could alleviate patients’ symptoms as quickly as 24 hours after administration and maintained effectiveness for at least four weeks.
Spravato is delivered via a nasal spray and must be taken under the supervision of a healthcare professional in a medical setting. Unlike traditional antidepressants that primarily work by regulating serotonin and dopamine levels in the brain, Spravato operates by enhancing glutamate activity. Glutamate is the brain’s most prevalent neurotransmitter and plays a crucial role in neuronal communication.
The sales of Spravato surged by 60% to $271 million in the second quarter compared to the same time last year. Johnson & Johnson reported that the drug has been used by 100,000 individuals across 77 countries.