Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, so it can be utilized as a standalone treatment for individuals with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designated for use alongside 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 280 million individuals worldwide living with major depressive disorder suffer from treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, commented in a press release that many patients struggling with difficult-to-treat depression often endure prolonged periods of trying various treatments that fail to alleviate their symptoms, leading to significant emotional and functional strain for both patients and their families.
The company’s application included findings from a late-stage clinical trial demonstrating that Spravato, when used alone, significantly alleviated symptoms as soon as 24 hours post-treatment and maintained this effect for at least four weeks.
Spravato is administered as a nasal spray and requires supervision from a healthcare provider in a clinical setting. Unlike traditional antidepressants that primarily target serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate serves as the brain’s most prevalent neurotransmitter, facilitating communication between neurons.
Sales of Spravato surged by 60% to reach $271 million for the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson reported that the medication has been used by 100,000 individuals across 77 countries.