Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) for the expansion of its ketamine-based medication, Spravato, as a standalone therapy for treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was initially indicated for use in combination with an oral antidepressant for patients who did not respond to two or more antidepressants. Approximately 30 percent of the estimated 280 million individuals globally affected by major depressive disorder are believed to suffer from treatment-resistant depression, according to Johnson & Johnson.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients with difficult-to-treat depression, 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 Spravato’s standalone use is backed by data from a late-stage clinical trial indicating that the medication can alleviate symptoms as early as 24 hours post-treatment and maintain effectiveness for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that impact serotonin and dopamine levels, Spravato enhances glutamate activity in the brain, which is the most prevalent neurotransmitter and plays a key role in neuronal communication.
Sales of Spravato surged by 60% to reach $271 million in the quarter ending June 30, compared to the same period in 2023. The medication has been utilized by 100,000 patients across 77 countries, according to Johnson & Johnson.