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, to allow it to be used as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients who have not experienced improvement after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people globally diagnosed with major depressive disorder suffer from treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated, “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 data from a late-stage clinical trial, which indicated that Spravato, when used as a standalone therapy, alleviated patients’ symptoms as quickly as 24 hours after treatment and sustained benefits for at least four weeks.
Spravato is administered as a nasal spray and must be given under the supervision of a healthcare professional in a clinical environment. Unlike traditional antidepressants that modify chemical levels such as serotonin and dopamine in the brain, Spravato functions by enhancing the activity of glutamate, the most prevalent neurotransmitter, which facilitates communication between neurons.
Sales of Spravato increased by 60% to $271 million during the three months ending June 30, compared to the same period in 2023. The medication has been used by approximately 100,000 patients across 77 countries, as reported by Johnson & Johnson.