Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based drug, Spravato, for use as a standalone therapy in treating resistant depression.
The FDA initially approved Spravato in 2019 to be used alongside an oral antidepressant for patients whose depression did not improve after trying two or more antidepressants. According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated, “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 FDA submission included data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, alleviated symptoms as soon as 24 hours after administration and continued to be effective for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike other antidepressants that target neurotransmitters like serotonin and dopamine, Spravato increases glutamate levels in the brain, which is the most prevalent neurotransmitter and is crucial for neuronal communication.
Sales for Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period last year. The drug is currently being utilized by 100,000 patients across 77 countries, according to Johnson & Johnson.