Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approval of its ketamine-based drug, Spravato, for use as a standalone treatment for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019, specifically for use alongside an oral antidepressant for patients whose depression had not improved after undergoing treatment with two or more antidepressants.
Approximately 30 percent of the estimated 280 million people globally with major depressive disorder suffer from treatment-resistant depression, according to Johnson & Johnson.
“Many patients enduring difficult-to-treat depression often spend excessive time trying various treatments that fail to alleviate their symptoms, resulting in significant functional and emotional challenges for both them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application included data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, began to alleviate symptoms as early as 24 hours after administration and continued to do so for at least four weeks.
Spravato is given as a nasal spray and must be administered under the watch of a healthcare provider within a healthcare facility. Unlike traditional antidepressants that target chemicals such as serotonin and dopamine in the brain, Spravato enhances the action of glutamate, the brain’s most prevalent neurotransmitter, facilitating communication between neurons.
Sales of Spravato surged by 60%, reaching $271 million during the three months ending June 30, compared to the same period in 2023. The drug has been utilized by 100,000 individuals across 77 countries, according to Johnson & Johnson.