Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based drug, Spravato, allowing it to be used as a standalone treatment for individuals with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designated for use alongside an oral antidepressant for patients who had not responded to two or more other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
“Many patients facing difficult-to-treat depression often find themselves cycling through numerous treatments that fail to adequately alleviate their symptoms, causing considerable emotional and functional strain on both them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application was supported by data from a late-stage clinical trial which indicated that Spravato, when used as a standalone treatment, could begin to alleviate patients’ symptoms as quickly as 24 hours post-treatment and maintain these effects for a minimum of four weeks.
Spravato is administered as a nasal spray and must be used under the supervision of a healthcare provider in a proper medical setting. Unlike traditional antidepressants that primarily affect neurotransmitters like serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter and plays a crucial role in neuronal communication.
Sales of Spravato surged by 60%, reaching $271 million for the three-month period ending June 30, compared to the same timeframe in 2023. As reported by Johnson & Johnson, the drug has been utilized by 100,000 individuals across 77 countries.