Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) seeking to extend the approval of its ketamine-based medication, Spravato, for use as a standalone treatment for individuals with treatment-resistant depression.
Initially approved in 2019, Spravato was authorized for use in conjunction with an oral antidepressant for patients who did not find relief from two or more previous antidepressants.
According to Johnson and Johnson, nearly 30% of the roughly 280 million people globally affected by major depressive disorder experience treatment-resistant depression.
“Many patients facing difficult-to-treat depression waste a lot of time going through various treatments without finding effective relief, leading to significant emotional and functional challenges for both themselves and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson.
The application to the FDA is supported by data from a late-stage clinical trial that indicated Spravato, when used alone, began to alleviate symptoms within 24 hours of treatment and maintained effectiveness for at least four weeks.
Spravato is administered via nasal spray and must be used under the supervision of a healthcare professional in a clinical environment. Unlike traditional antidepressants that alter neurotransmitters like serotonin and dopamine, Spravato acts by increasing levels of glutamate, the brain’s most prevalent neurotransmitter, which facilitates communication between neurons.
Sales of Spravato surged by 60% to $271 million during the three-month period ending June 30 compared to the same timeframe last year. The medication has been utilized by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.