Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the approval of its ketamine-based drug, Spravato, allowing it to be used as a standalone treatment for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying at least two other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
“Many patients facing difficult-to-treat depression often spend excessive time trying different treatments that fail to alleviate their symptoms, which can impose significant functional and emotional burdens on both them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application is supported by data from a late-stage clinical trial indicating that Spravato, when administered as a standalone treatment, began alleviating patients’ symptoms within 24 hours and continued to be effective for at least four weeks.
Spravato is administered as a nasal spray and requires supervision by a healthcare provider in a clinical setting. Unlike traditional antidepressants that primarily manipulate serotonin and dopamine levels in the brain, Spravato functions by increasing levels of glutamate, the most prevalent neurotransmitter, which facilitates communication between neurons.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same quarter in 2023. According to Johnson & Johnson, the drug has been utilized by 100,000 individuals across 77 countries.