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-derived medication, Spravato, to function as a standalone treatment for individuals with treatment-resistant depression.
Originally authorized by the FDA in 2019, Spravato was approved to be used alongside an oral antidepressant for patients who did not respond to two or more antidepressant therapies. Approximately 30 percent of the estimated 280 million individuals globally suffering from major depressive disorder experience treatment-resistant depression, as noted by Johnson & Johnson.
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 was backed by data from a late-stage clinical trial that indicated Spravato, when used alone, alleviated patients’ symptoms within 24 hours of treatment and maintained effectiveness for at least four weeks.
Spravato is delivered via a nasal spray and requires administration under the supervision of a healthcare professional in a medical environment. Unlike traditional antidepressants that adjust neurotransmitters such as serotonin and dopamine, Spravato enhances levels of glutamate, the brain’s most prevalent neurotransmitter, facilitating communication between neurons.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in 2022. The medication has been utilized by 100,000 patients across 77 countries, as reported by Johnson & Johnson.