Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the approved use of its ketamine-based drug, Spravato, as a standalone treatment for treatment-resistant depression.
Initially, the FDA approved Spravato in 2019 to be used alongside an oral antidepressant for individuals who did not see improvements after trying two or more antidepressants. Approximately 30 percent of the estimated 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression, according to Johnson & Johnson.
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 includes data from a late-stage clinical trial that indicated Spravato, when used alone, successfully alleviated symptoms as quickly as 24 hours after treatment and sustained relief for at least four weeks.
Spravato is administered as a nasal spray under the supervision of a healthcare provider in a medical setting. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato functions by enhancing levels of glutamate in the brain. Glutamate is the most prevalent neurotransmitter in the brain, facilitating communication between neurons.
Sales for Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in 2022. The drug has been utilized by 100,000 individuals across 77 countries, according to Johnson & Johnson.