Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based medication, Spravato, as a standalone treatment for treatment-resistant depression.
Initially approved in 2019, Spravato was designed to be used in conjunction with 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 estimated 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release, “Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones.”
The application to the FDA includes results from a late-stage clinical trial indicating that Spravato, when used alone, alleviated patients’ symptoms as soon as 24 hours after administration and maintained this improvement for at least four weeks.
Spravato is delivered via nasal spray and must be administered under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate, the brain’s most prevalent neurotransmitter that facilitates neuronal communication.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same time frame in 2023. To date, approximately 100,000 individuals in 77 countries have utilized Spravato, according to Johnson & Johnson.