Johnson & Johnson announced on Monday that it has submitted a proposal to the U.S. Food and Drug Administration (FDA) seeking to broaden the approved use of its ketamine-based medication, Spravato, to serve as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients whose conditions did not improve despite trying two or more other antidepressants. Johnson & Johnson estimates that nearly 30 percent of the approximately 280 million people suffering from major depressive disorder are affected by 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 results from a late-stage clinical trial, indicating that Spravato, when used alone, can alleviate symptoms as quickly as 24 hours after administration and remain effective for at least four weeks.
Spravato is delivered via nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that primarily target neurotransmitters such as serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, which is the most prevalent neurotransmitter and plays a crucial role in neuronal communication.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30 compared to the same period in 2023. According to Johnson & Johnson, the drug has been utilized by 100,000 individuals across 77 countries.