Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based treatment, Spravato, to act as a standalone therapy for individuals suffering from treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designed to be used in conjunction with an oral antidepressant for patients who did not see improvements after trying two or more different antidepressant medications. According to the company, nearly 30 percent of the estimated 280 million people globally diagnosed with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the struggles many patients face, 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 was supported by data from a late-stage clinical trial demonstrating that Spravato, when used alone, could alleviate patients’ symptoms as early as 24 hours post-treatment and maintain those improvements for at least four weeks.
Spravato is administered as a nasal spray and must be provided under medical supervision in a healthcare environment. Unlike traditional antidepressants that often modulate serotonin and dopamine levels, Spravato enhances glutamate activity in the brain, which is essential for neuron communication.
In financial news, sales of Spravato surged 60% to reach $271 million in the quarter ending June 30, compared to the same timeframe in 2023. The medication has been utilized by approximately 100,000 individuals across 77 countries, as reported by Johnson & Johnson.