Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based medication, Spravato, allowing it to be used as a standalone therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients who did not respond to two or more prior antidepressants. Approximately 30 percent of the estimated 280 million people worldwide with major depressive disorder suffer from treatment-resistant depression, according to the company.
Bill Martin, head of neuroscience at Johnson & Johnson, said 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 for the expanded use of Spravato was supported by data from a late-stage clinical trial indicating that the treatment effectively reduced symptoms as early as 24 hours after administration and maintained improvement for at least four weeks.
Spravato is delivered as a nasal spray and is required to be taken under the supervision of a healthcare provider in a clinical environment. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances glutamate activity in the brain. Glutamate is the most prevalent neurotransmitter and is crucial for communication between neurons.
In terms of performance, sales of Spravato surged by 60%, reaching $271 million for the quarter ending June 30, compared to the same period in the previous year. The drug has been utilized by over 100,000 individuals across 77 countries, as reported by Johnson & Johnson.