Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the approved use of its ketamine-based medication, Spravato, for treatment-resistant depression as a standalone therapy.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients who did not respond to two or more other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression. Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release that many patients endure prolonged struggles with ineffective treatments, imposing significant emotional and functional burdens on them and their families.
The application included results from a late-stage clinical trial demonstrating that Spravato can alleviate symptoms as quickly as 24 hours after administration and maintain effectiveness for at least four weeks.
Spravato is delivered via nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that target chemicals such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is crucial for neuronal communication.
Sales for Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. The medication has already been utilized by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.