Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, to function as a standalone treatment for individuals suffering from treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designated for use alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people worldwide living with major depressive disorder experience treatment-resistant depression.
Bill Martin, 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 submission was backed by data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone treatment, alleviated patients’ symptoms as soon as 24 hours after administration and maintained effectiveness 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 primarily adjust chemicals like serotonin and dopamine in the brain, Spravato enhances glutamate levels, which is the brain’s most prevalent neurotransmitter, aiding neuronal communication.
Sales of Spravato surged by 60% to $271 million for the three months ending June 30, compared to the same period in 2023. Johnson & Johnson reports that the drug has been utilized by 100,000 individuals across 77 countries.