Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) seeking to extend 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 authorized 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 approximately 280 million individuals worldwide diagnosed with major depressive disorder experience treatment-resistant depression.
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 application to the FDA was supported by data from a late-stage clinical trial that indicated Spravato, when used as a standalone treatment, could alleviate patients’ symptoms as quickly as 24 hours after administration and maintain these effects for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare professional in a clinical setting. Unlike other antidepressants that adjust levels of serotonin and dopamine, Spravato enhances the activity of glutamate in the brain, which is the most prevalent neurotransmitter and facilitates communication between neurons.
Sales for Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson reported that the medication has been utilized by 100,000 patients across 77 countries.