Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) seeking to broaden the approved use of its ketamine-based drug, Spravato, to function as a standalone therapy for individuals with treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was permitted for use alongside an oral antidepressant for patients whose conditions did not improve after trying two or more different antidepressants.
According to Johnson & Johnson, nearly 30 percent of the 280 million people globally diagnosed with major depressive disorder suffer from 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 includes data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, provided relief from symptoms as soon as 24 hours after administration and sustained effects for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the oversight of a healthcare professional in a medical setting. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato functions by increasing levels of glutamate in the brain, which is the most prevalent neurotransmitter and is vital for neuronal communication.
Sales of Spravato experienced a significant increase of 60%, reaching $271 million for the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson reported that Spravato has been utilized by over 100,000 individuals across 77 countries.