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 drug, Spravato, as a standalone treatment for resistant depression.
Spravato was first approved by the FDA in 2019 for use alongside an oral antidepressant for patients whose condition did not improve after trying two or more different antidepressants.
According to Johnson & Johnson, nearly 30% of the approximately 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, highlighted the challenges faced by patients with difficult-to-treat depression, stating that many endure lengthy periods trying various treatments that fail to alleviate their symptoms, resulting in significant emotional and functional stress for both patients and their families.
The new application was supported by data from a late-stage clinical trial, which found that Spravato, when used alone, alleviated symptoms in patients as quickly as 24 hours after administration and maintained effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under medical supervision in a healthcare environment. Unlike traditional antidepressants that typically target neurotransmitters such as serotonin and dopamine, Spravato operates by increasing levels of glutamate in the brain, a crucial neurotransmitter that facilitates communication between neurons.
Sales figures for Spravato indicate a 60% rise, reaching $271 million for the quarter ending June 30, compared to the same quarter in 2023. The drug has been prescribed to over 100,000 individuals across 77 nations, according to the company.