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, to be utilized as a standalone treatment for individuals suffering from treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was authorized for use in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more different antidepressants.
According to Johnson & Johnson, nearly 30 percent of the 280 million individuals worldwide diagnosed with 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 to expand Spravato’s use is backed by data from a late-stage clinical trial indicating that the medication, when used alone, can alleviate symptoms in patients as soon as 24 hours after treatment and maintain these improvements for at least four weeks.
Spravato is administered via a nasal spray, requiring supervision by a healthcare provider. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato functions by enhancing levels of glutamate in the brain, a key neurotransmitter that facilitates communication between neurons.
Sales of Spravato increased by 60%, reaching $271 million in the quarter ending June 30, 2023, compared to the same period last year. The medication has been utilized by 100,000 individuals across 77 countries, per Johnson & Johnson.