Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) seeking to expand the approved use of its ketamine-based medication, Spravato, for use as a standalone therapy aimed at treating resistant depression.
Originally approved by the FDA in 2019, Spravato was designated to be used alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more other antidepressants.
Johnson & Johnson emphasized that nearly 30 percent of the approximately 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression. Bill Martin, the head of neuroscience at Johnson & Johnson, noted in a press release, “Many patients dealing with difficult-to-treat depression endure long periods cycling through various treatments that fail to effectively alleviate their symptoms, leading to considerable functional and emotional strain on themselves and their families.”
The application submitted includes data from a late-stage clinical trial, indicating that Spravato as a standalone treatment can alleviate symptoms within 24 hours and continue to be effective for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare professional in a clinical environment. Unlike traditional antidepressants that primarily target neurotransmitters such as serotonin and dopamine, Spravato enhances the activity of glutamate in the brain. Glutamate is the brain’s most prevalent neurotransmitter and plays a crucial role in the communication between neurons.
Sales for Spravato surged by 60%, reaching $271 million in the three months ending June 30, compared to the same period in 2023. Johnson & Johnson reported that the treatment has already been utilized by 100,000 patients across 77 countries.