Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based medication, Spravato, to serve as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants. Johnson & Johnson highlighted that nearly 30 percent of the approximately 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, noted in a press release that many patients enduring difficult-to-treat depression often spend excessive time cycling through various ineffective treatments, resulting in significant emotional and functional challenges for both themselves and their families.
The application was supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, alleviated patients’ symptoms within 24 hours and continued to do so for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a clinical setting. Unlike conventional antidepressants that influence brain chemicals such as serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate is a critical neurotransmitter that 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 the prior year. Johnson & Johnson reported that Spravato has been utilized by 100,000 individuals across 77 countries.