Johnson & Johnson announced on Monday that it has submitted a proposal to the U.S. Food and Drug Administration (FDA) seeking to extend the approved use of its ketamine-based drug, Spravato, to function as a standalone treatment for individuals suffering from treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants. Johnson & Johnson reported that nearly 30 percent of the estimated 280 million people globally who have major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, noted 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 recent application was backed by data from a late-stage clinical trial, which indicated that Spravato as a standalone treatment alleviated symptoms in patients as early as 24 hours after administration and maintained efficacy 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 primarily target serotonin and dopamine levels, Spravato enhances glutamate levels in the brain. Glutamate is the brain’s most prevalent neurotransmitter, essential for neuronal communication.
Sales for Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in the previous year. The drug has been administered to 100,000 individuals across 77 countries, according to Johnson & Johnson.