Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms had not improved after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the around 280 million people globally suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated, “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 includes data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, demonstrated symptom relief in patients as quickly as 24 hours after administration, lasting for at least four weeks.
Spravato is delivered as a nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that modify serotonin and dopamine levels in the brain, Spravato enhances glutamate, the most prevalent neurotransmitter, facilitating communication between neurons.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in 2022. The medication has been administered to 100,000 individuals across 77 countries, according to the company.