Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) seeking approval to expand the use of its ketamine-based drug, Spravato, allowing it to be administered as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 to be used in conjunction with an oral antidepressant for patients whose conditions did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide suffering from major depressive disorder face 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 application for expanded use was supported by data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone treatment, can alleviate symptoms as quickly as 24 hours after administration and maintain this effect for at least four weeks.
Spravato is delivered as a nasal spray and must be used under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that adjust levels of chemicals like serotonin and dopamine in the brain, Spravato enhances the action of glutamate, the brain’s most abundant neurotransmitter, facilitating neuron communication.
Sales of Spravato have experienced a significant increase, surging 60% to $271 million in the quarter ending June 30, compared to the same period in 2022. Johnson & Johnson noted that the drug has been utilized by 100,000 patients across 77 countries.