Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based drug, Spravato, as a standalone treatment for individuals with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designed to be used in conjunction with an oral antidepressant for patients whose depression did not improve after attempting two or more antidepressant therapies.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide living with major depressive disorder suffer from treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the struggles faced by these individuals, stating, “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 includes data from a late-stage clinical trial indicating that Spravato can relieve symptoms of depression as early as 24 hours after treatment and maintain effectiveness for at least four weeks.
Spravato is delivered via a nasal spray and must be administered in a healthcare setting under the supervision of a qualified provider. Unlike traditional antidepressants that primarily target serotonin and dopamine levels, Spravato enhances glutamate activity in the brain, which is the most abundant neurotransmitter, facilitating communication between neurons.
Sales of Spravato experienced a substantial increase of 60%, reaching $271 million for the quarter ending June 30, compared to the same period in 2023. To date, the drug has been utilized by approximately 100,000 patients across 77 countries.