Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based drug, Spravato, allowing it to be employed as a standalone treatment for individuals suffering from treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients who did not see improvement after trying two or more other antidepressants. Johnson & Johnson estimates that nearly 30 percent of the approximately 280 million people globally affected by major depressive disorder are dealing with treatment-resistant depression.
Bill Martin, the 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, which can cause a significant functional and emotional burden on patients and their loved ones.”
The submission to the FDA is supported by data from a late-stage clinical trial that indicated Spravato, when used alone, could alleviate symptoms in patients as quickly 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 environment. Unlike traditional antidepressants that focus on regulating neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain, a neurotransmitter that plays a crucial role in neuronal communication.
Sales of Spravato have seen a remarkable increase, rising 60% to $271 million in the quarter ending June 30 compared to the same period in 2023. The drug has been utilized by around 100,000 patients across 77 countries, according to Johnson & Johnson.