Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based medication, Spravato, to be utilized as a standalone therapy for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was authorized for use in conjunction with an oral antidepressant in patients whose symptoms persisted despite trying two or more antidepressants. Johnson & Johnson noted that nearly 30 percent of the approximately 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release the pressing need for effective solutions, stating, “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 company’s application is supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, showed improvement in patients’ symptoms within just 24 hours and continued to be effective for at least four weeks.
Spravato is administered as a nasal spray and requires supervision from a healthcare provider during its use. Unlike traditional antidepressants that primarily affect serotonin and dopamine levels, Spravato functions by increasing glutamate, the brain’s most prevalent neurotransmitter, which facilitates communication between neurons.
Sales for Spravato surged by 60%, reaching $271 million in the three months ending June 30, compared to the same period in 2023. Johnson & Johnson reported that the medication has been used by 100,000 individuals across 77 countries.