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 medication, Spravato, allowing it to be utilized as a standalone therapy for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designated for use in conjunction with an oral antidepressant for patients whose symptoms remained unmanageable despite trying two or more antidepressants.
According to Johnson & Johnson, around 30 percent of the approximately 280 million individuals worldwide suffering from major depressive disorder experience 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 is supported by data from a late-stage clinical trial, demonstrating that Spravato, as a standalone treatment, was able to alleviate patients’ symptoms within 24 hours after administration and maintained effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that primarily influence chemicals like serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter and facilitates communication between neurons.
Sales for Spravato experienced a significant increase of 60%, reaching $271 million for the quarter ending June 30, compared to the same period in 2022. The medication has been utilized by approximately 100,000 individuals across 77 countries, as reported by Johnson & Johnson.