Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden its approval for the ketamine-based medication Spravato, allowing it to be used as a standalone treatment for patients with treatment-resistant depression.
Spravato was initially authorized by the FDA in 2019, meant to be administered alongside an oral antidepressant for individuals whose symptoms did not improve after trying two or more other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people globally suffering from major depressive disorder experience treatment-resistant depression.
“Many patients dealing with difficult-to-treat depression often spend an excessive amount of time trying numerous treatments that fail to alleviate their symptoms, which can lead to significant functional and emotional distress for both the patients and their families,” stated Bill Martin, Johnson & Johnson’s head of neuroscience, in a press release.
The FDA application includes data from a late-stage clinical trial that indicated Spravato, when used on its own, was effective in reducing symptoms within 24 hours of treatment and sustained relief for at least four weeks.
Spravato is administered through a nasal spray and is required to be taken under the supervision of a healthcare professional in a clinical environment. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter, facilitating communication between neurons.
Sales of Spravato have surged by 60% to reach $271 million in the quarter ending June 30, compared to the same quarter last year. Johnson & Johnson reports that the drug has been utilized by 100,000 patients across 77 countries.