Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based medication, Spravato, as a standalone treatment for treatment-resistant depression.
Initially approved in 2019, Spravato was designated for use alongside an oral antidepressant for patients who did not find relief after trying two or more such medications. Johnson & Johnson has highlighted that nearly 30 percent of the estimated 280 million people globally who suffer from major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, remarked in a press release that individuals dealing with difficult-to-treat depression often endure prolonged periods trying multiple treatments that fail to alleviate their symptoms, leading to significant emotional and functional challenges for both patients and their families.
The FDA application is supported by results from a late-stage clinical trial indicating that Spravato, when used as a standalone therapy, began to alleviate patient symptoms as soon as 24 hours after treatment and continued to do so for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that modify neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate activity in the brain, a crucial neurotransmitter that facilitates communication between neurons.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in the previous year. The medication has been used by approximately 100,000 patients across 77 countries, according to Johnson & Johnson.