Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the usage of its ketamine-based medication, Spravato, allowing it to be administered as a standalone treatment for patients with treatment-resistant depression.
Approved by the FDA in 2019, Spravato was initially designated for use alongside an oral antidepressant for individuals whose symptoms failed to improve after trying two or more other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the 280 million individuals worldwide diagnosed with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release that many patients enduring difficult-to-treat depression often spend an excessive amount of time trying various treatments that ultimately do not alleviate their symptoms, resulting in significant emotional and functional strain on both themselves and their families.
The application for expanded usage was supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone therapy, demonstrated symptom relief for patients as early as 24 hours post-treatment and continued to do so for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a clinical environment. Unlike traditional antidepressants that focus on balancing neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain—a key neurotransmitter that facilitates neuronal communication.
Sales for Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson reported that Spravato has been utilized by approximately 100,000 patients across 77 countries.