Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based medication, Spravato, as a standalone treatment for individuals suffering from treatment-resistant depression.
Spravato was originally approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients who do not find relief from their symptoms after trying two or more antidepressants. According to Johnson & Johnson, approximately 30 percent of the estimated 280 million people globally diagnosed with major depressive disorder experience treatment-resistant depression.
Bill Martin, the 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 for the new use was supported by data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone treatment, could alleviate patients’ symptoms within 24 hours of administration and provide effects lasting at least four weeks.
Spravato is delivered as a nasal spray and is required to be administered under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants, which often focus on regulating neurotransmitters like serotonin and dopamine, Spravato functions by enhancing levels of glutamate in the brain, a key neurotransmitter that facilitates communication between neurons.
Sales for Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in the previous year. Johnson & Johnson reports that the drug has been utilized by 100,000 individuals across 77 countries.