Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) seeking to expand the approved use of its ketamine-based medication Spravato for treatment-resistant depression, allowing it to be utilized as a standalone therapy.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose depression has not improved after trying two or more other antidepressants. According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide living with major depressive disorder suffer from treatment-resistant depression.
Bill Martin, the 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 to the FDA includes findings from a late-stage clinical trial indicating that Spravato, when used alone, can alleviate patients’ symptoms as quickly as 24 hours after treatment and can continue to do so for at least four weeks.
Spravato is administered as a nasal spray and must be taken in a healthcare setting under the supervision of a medical professional. Unlike other antidepressants that target chemicals like serotonin and dopamine in the brain, Spravato functions by enhancing glutamate levels, the most abundant neurotransmitter that facilitates communication between neurons.
Sales of Spravato rose by 60% to $271 million during the three-month period ending June 30, compared to the same timeframe last year. The drug has been used by 100,000 individuals across 77 countries, according to Johnson & Johnson.