Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based medication, Spravato, for treating resistant depression as a standalone therapy.
Initially approved by the FDA in 2019, Spravato was designated for use in conjunction with an oral antidepressant in patients whose symptoms failed to improve after trying two or more antidepressants.
Johnson & Johnson reported that 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 application for expanded use was backed by data from a late-stage clinical trial indicating that Spravato, when administered as a standalone treatment, alleviated patients’ symptoms as quickly as 24 hours post-treatment and continued to provide relief for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a clinical environment. Unlike other antidepressants that target neurotransmitters like serotonin and dopamine, Spravato acts by enhancing glutamate, the most prevalent neurotransmitter in the brain, facilitating communication between neurons.
Sales of Spravato surged by 60% to $271 million for the quarter ending June 30, compared to the same timeframe in 2023. Johnson & Johnson noted that Spravato has been utilized by 100,000 patients across 77 countries.