Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based medication, Spravato, to function as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside oral antidepressants for patients whose symptoms did not improve after trying two or more antidepressant medications. The company noted that approximately 30 percent of the estimated 280 million individuals worldwide suffering 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 application for expanded use is backed by results from a late-stage clinical trial, which demonstrated that Spravato, when used as a standalone treatment, alleviated patients’ symptoms within 24 hours and maintained effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a medical setting. Unlike traditional antidepressants that target brain chemicals like serotonin and dopamine, Spravato enhances the activity of glutamate, the brain’s most prevalent neurotransmitter, facilitating communication between neurons.
Sales of Spravato increased by 60% to $271 million for the quarter ending June 30, compared to the same period in the previous year. Johnson & Johnson reported that Spravato has been utilized by 100,000 individuals across 77 countries.