Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to extend the approved use of its ketamine-based medication, Spravato, as a standalone treatment for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designed to be used alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more different antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
“Patients grappling with difficult-to-treat depression often endure prolonged periods trying varied treatments that fail to alleviate their symptoms, imposing a considerable emotional and functional burden on both them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The company’s application is backed by results from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, can alleviate symptoms as quickly as 24 hours after administration and maintain effectiveness 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 medical facility. Unlike traditional antidepressants, which typically affect neurotransmitters like serotonin and dopamine, Spravato primarily enhances the brain’s glutamate levels. Glutamate is the most prevalent neurotransmitter in the brain and plays a crucial role in neuronal communication.
Sales of Spravato surged by 60% to $271 million for the quarter ending June 30 compared to the same period in 2023. The medication has been utilized by approximately 100,000 patients across 77 countries, as reported by Johnson & Johnson.