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, for treating resistant depression as a solo therapy.
Initially authorized by the FDA in 2019, Spravato was approved for use alongside an oral antidepressant for patients whose conditions did not improve with two or more previous antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, expressed concern about the lengthy treatment journeys many patients endure. He 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 includes findings from a late-stage clinical trial indicating that Spravato, when used alone, could alleviate symptoms in patients as quickly as 24 hours after administration and provide relief for at least four weeks.
Spravato is given as a nasal spray and must be administered under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that target serotonin and dopamine, Spravato works by increasing glutamate levels in the brain, enhancing communication between neurons.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2022. Johnson & Johnson reports that Spravato has been utilized by 100,000 people across 77 countries.