Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to modify the approved use of its ketamine-based drug, Spravato, so that it can be utilized as a standalone therapy for treatment-resistant depression.
The FDA originally approved Spravato in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide suffering from 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 was supported by data from a late-stage clinical trial, which indicated that using Spravato as a standalone treatment began alleviating symptoms within 24 hours and continued 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 environment. Unlike traditional antidepressants that target chemicals like serotonin and dopamine in the brain, Spravato functions by enhancing glutamate levels, the most abundant neurotransmitter, facilitating communication between neurons.
Sales of Spravato grew by 60% to $271 million during the three months ending June 30, compared to the same period in 2023. The drug has been utilized by 100,000 patients across 77 countries, according to Johnson & Johnson.