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 medication, Spravato, to be utilized as a standalone treatment for patients with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019, but only in conjunction with an oral antidepressant for individuals whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people globally diagnosed with major depressive disorder suffer from 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 FDA application is bolstered by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, alleviated patients’ symptoms within 24 hours of administration and continued to provide relief for at least four weeks.
Spravato is delivered via a nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that affect neurotransmitters like serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, which is the predominant neurotransmitter facilitating communication between neurons.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period last year. To date, Spravato has been used by 100,000 individuals across 77 countries.