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 treatment for individuals with treatment-resistant depression.
Spravato was originally approved by the FDA in 2019 for use alongside an oral antidepressant for patients whose conditions did not improve after trying two or more antidepressants.
Johnson & Johnson highlighted that nearly 30 percent of the approximately 280 million individuals worldwide who suffer 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, leading to a significant emotional and functional burden on both them and their loved ones.”
The application includes data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, was effective in alleviating patients’ symptoms as soon as 24 hours after administration and for a duration of at least four weeks.
Spravato is delivered via nasal spray and must be administered under the supervision of a healthcare provider in a professional setting. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter, playing a crucial role in neuronal communication.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in 2023. According to Johnson & Johnson, the medication has been used by 100,000 individuals across 77 countries.