Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) for the approval to use its ketamine-based medication, Spravato, as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients whose conditions did not improve despite trying two or more antidepressants.
According to Johnson & Johnson, approximately 30 percent of the 280 million individuals globally who suffer from 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 FDA application includes data from a late-stage clinical trial indicating that Spravato, when used alone, alleviated symptoms in patients as quickly as 24 hours after treatment and continued to provide relief for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare professional. Unlike traditional antidepressants that target brain chemicals like serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter and plays a key role in neuronal communication.
Sales of Spravato rose 60% to $271 million in the quarter ending June 30, compared to the same period last year. The drug has been used by approximately 100,000 individuals across 77 countries, according to Johnson & Johnson.