Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based medication, Spravato, as a standalone treatment for individuals with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was authorized for use in conjunction with oral antidepressants for patients who did not see improvement after trying two or more antidepressants.
The company highlighted that nearly 30 percent of the approximately 280 million people globally who suffer from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release that, “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 was supported by data from a late-stage clinical trial, which indicated that Spravato, when used as a standalone treatment, significantly improved patient symptoms within 24 hours and maintained these benefits for at least four weeks.
Spravato is administered as a nasal spray and must be given under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that focus on regulating neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain, aiding neural communication.
Sales of Spravato increased by 60% to $271 million in the quarter ending June 30, compared to the same period in the previous year. Johnson & Johnson reported that the medication has been utilized by 100,000 patients across 77 countries.