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, to serve as a standalone therapy for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designed to be used alongside an oral antidepressant for patients who did not experience improvement after taking two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people worldwide suffering from major depressive disorder have 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 application to the FDA was supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, alleviated patients’ symptoms as early as 24 hours after administration and maintained efficacy for a minimum of four weeks.
Spravato is delivered via nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that focus on regulating neurotransmitters such as serotonin and dopamine, Spravato enhances the action of glutamate, the brain’s most abundant neurotransmitter, facilitating neuronal communication.
Sales for Spravato rose by 60%, reaching $271 million in the quarter ending June 30, compared to the same period the previous year. As reported by Johnson & Johnson, the drug has been utilized by 100,000 patients across 77 countries.