Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approval of its ketamine-based medication, Spravato, for use as a standalone treatment for treatment-resistant depression.
The FDA initially approved Spravato in 2019 for use alongside an oral antidepressant for patients whose depression did not improve after trying two or more antidepressants.
Johnson & Johnson reported that nearly 30 percent of the 280 million individuals worldwide affected by 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, which can cause a significant functional and emotional burden on patients and their loved ones.”
The application submitted to the FDA includes data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, can alleviate symptoms as soon as 24 hours after administration and continue to be effective for at least four weeks.
Spravato is administered via nasal spray and must be taken in the presence of a healthcare provider. Unlike traditional antidepressants that target brain chemicals like serotonin and dopamine, Spravato functions by enhancing glutamate activity in the brain, a key neurotransmitter that facilitates communication between neurons.
In the second quarter of 2023, sales of Spravato surged by 60%, reaching $271 million compared to the same period the previous year. Johnson & Johnson also reported that the drug has been utilized by 100,000 patients across 77 countries.