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 in 2019, Spravato was authorized for use alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more other antidepressants. Johnson & Johnson highlighted that nearly 30 percent of the 280 million people globally living with major depressive disorder experience treatment-resistant depression.
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 FDA submission was supported by data from a late-stage clinical trial, which demonstrated that Spravato, when used alone, alleviated patients’ symptoms as quickly as 24 hours after administration and maintained effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be taken under the supervision of a healthcare provider in a designated healthcare setting. Unlike traditional antidepressants that target serotonin and dopamine levels, Spravato functions by increasing glutamate activity, the brain’s most prevalent neurotransmitter that facilitates neuron communication.
In terms of market performance, sales of Spravato surged by 60% to $271 million during the second quarter of 2023 compared to the same period last year. Johnson & Johnson reported that the medication has been utilized by 100,000 individuals across 77 countries.