Johnson & Johnson announced on Monday that it has submitted an application 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 designed to be used in conjunction with an oral antidepressant for patients whose symptoms did not respond to at least two other antidepressant medications.
Johnson & Johnson indicated that nearly 30 percent of the approximately 280 million people worldwide living with major depressive disorder experience treatment-resistant depression.
“Many patients suffering from difficult-to-treat depression endure lengthy cycles of ineffective treatments, leading to a substantial emotional and functional burden on themselves and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application was supported by data from a late-stage clinical trial that demonstrated that Spravato, when used alone, alleviated patients’ symptoms as quickly as 24 hours after treatment and continued to provide relief for a minimum of four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare professional in a clinical environment. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato enhances the activity of glutamate in the brain. Glutamate is the most prevalent neurotransmitter, facilitating communication between neurons.
Sales of Spravato soared by 60% to $271 million in the three months ending June 30, compared to the same period in 2023. The treatment has been utilized by 100,000 individuals across 77 countries, according to Johnson & Johnson.