Johnson & Johnson announced on Monday that it has submitted an application 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 treatment for patients with treatment-resistant depression.
Initially approved in 2019 for use alongside an oral antidepressant for individuals whose symptoms did not improve after trying two or more antidepressants, Spravato was developed to address the needs of the approximately 30 percent of the 280 million people globally suffering from major depressive disorder who experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated that patients enduring difficult-to-treat depression often cycle through various treatments that fail to alleviate their symptoms, leading to a significant emotional and functional burden for both patients and their families.
The application to the FDA is supported by data from a late-stage clinical trial which indicated that Spravato, when used alone, began to alleviate symptoms as quickly as 24 hours after administration and continued to be effective for at least four weeks.
Spravato is delivered as a nasal spray and must be administered in a healthcare setting under the supervision of a healthcare provider. Unlike traditional antidepressants that target chemicals like serotonin and dopamine, Spravato enhances the action of glutamate, the brain’s most abundant neurotransmitter, which is essential for neuronal communication.
Sales of Spravato increased by 60%, reaching $271 million in the three months ending June 30, compared to the same period in 2022. According to Johnson & Johnson, Spravato has been used by 100,000 patients across 77 countries.