Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based drug, Spravato, as a standalone treatment for patients with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was authorized for use alongside an oral antidepressant for individuals whose symptoms did not improve after trying two or more standard antidepressants.
According to Johnson & Johnson, nearly 30% of the approximately 280 million people globally suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release, “Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones.”
The new application includes data from a late-stage clinical trial that indicated Spravato, when used alone, could alleviate symptoms for some patients as soon as 24 hours after treatment and maintain its effects for at least four weeks.
Spravato is administered as a nasal spray and must be used under the supervision of a healthcare professional in a clinical setting. Unlike other antidepressants that target serotonin and dopamine levels, Spravato increases glutamate activity in the brain, which is the most abundant neurotransmitter and facilitates communication between neurons.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in 2022. Johnson & Johnson reported that Spravato has been prescribed to 100,000 patients across 77 countries.