Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based drug, Spravato, allowing it to be utilized as a standalone therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 as an adjunct to an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants.
Approximately 30 percent of the estimated 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression, according to Johnson & Johnson.
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 application includes findings from a late-stage clinical trial that indicated Spravato, when used alone, alleviated patients’ symptoms within 24 hours and sustained relief for at least four weeks.
Spravato is administered as a nasal spray and must be given under the supervision of a healthcare provider in a clinical setting. Unlike other antidepressants that primarily target serotonin and dopamine levels in the brain, Spravato enhances glutamate, the brain’s most abundant neurotransmitter, facilitating communication between neurons.
Sales of Spravato surged by 60% to $271 million for the quarter ending June 30 compared to the same period last year. Johnson & Johnson reports that Spravato has been used by 100,000 people across 77 countries.