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, for use as a standalone treatment for patients with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 to be used alongside an oral antidepressant for individuals whose symptoms did not respond to two or more previous antidepressant therapies. The pharmaceutical company noted that nearly 30 percent of the estimated 280 million people worldwide living with major depressive disorder suffer from treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, commented on the burden faced by patients with difficult-to-treat depression, stating that many spend too much time trying various treatments that do not alleviate their symptoms. This, he explained, can lead to significant emotional and functional challenges for both the patients and their families.
The application included data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, could reduce patients’ symptoms as soon as 24 hours after administration and provide relief for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that primarily affect serotonin and dopamine levels in the brain, Spravato enhances glutamate activity. Glutamate is the brain’s most prevalent neurotransmitter and plays a crucial role in neuronal communication.
Sales of Spravato experienced a significant increase of 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. So far, the drug has been utilized by 100,000 patients across 77 countries, as reported by Johnson & Johnson.