Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone therapy for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designated for use alongside an oral antidepressant for patients who did not respond to two or more other antidepressants. Johnson & Johnson highlighted that nearly 30 percent of the estimated 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the difficulties faced by patients enduring hard-to-treat depression. “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,” he stated in a press release.
The application to the FDA was accompanied by results from a late-stage clinical trial demonstrating that Spravato, as a standalone treatment, alleviated symptoms in patients within 24 hours and provided relief for at least four weeks.
Spravato is administered as a nasal spray and must be used under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that adjust chemicals like serotonin and dopamine in the brain, Spravato functions by enhancing levels of glutamate, the most prevalent neurotransmitter, which aids communication between neurons.
In financial news, sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson reported that Spravato has been administered to 100,000 individuals across 77 countries.