Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based drug, Spravato, allowing it to be utilized as a standalone therapy for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was authorized for use in conjunction with an oral antidepressant for patients whose conditions did not respond to two or more prior antidepressant treatments. Johnson & Johnson noted that nearly 30 percent of the approximately 280 million individuals worldwide affected by major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients suffering from 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 to the FDA is supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, significantly alleviated symptoms in patients within 24 hours and maintained improvements for at least four weeks.
Spravato is administered as a nasal spray and must be taken in a healthcare setting under professional supervision. Unlike traditional antidepressants that primarily affect serotonin and dopamine levels, Spravato enhances glutamate activity in the brain, which is the most abundant neurotransmitter and plays a crucial role in neuronal communication.
Sales of Spravato experienced a substantial increase, rising 60% to $271 million in the quarter ending June 30, compared to the same period in 2023. The drug has been utilized by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.