Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the approved use of its ketamine-based drug, Spravato, as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms did not improve after attempting two or more antidepressants.
According to Johnson & Johnson, around 30 percent of the approximately 280 million people worldwide living with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, commented 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, causing a significant functional and emotional burden on both patients and their loved ones.”
The application for expanded use is supported by data from a late-stage clinical trial, which indicated that Spravato, when used as a standalone treatment, alleviated symptoms in patients as quickly as 24 hours after administration and sustained improvements 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 traditional antidepressants that modify neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most common neurotransmitter that facilitates communication between neurons.
Sales of Spravato increased by 60% to $271 million in the three months ending June 30 compared to the same period in the previous year. The drug has been utilized by 100,000 patients across 77 countries, according to Johnson & Johnson.