Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, allowing it to be a standalone treatment for individuals with 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 approximately 280 million people globally living 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 significant functional and emotional burdens on patients and their loved ones.”
The application is supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, can help alleviate patients’ symptoms within just 24 hours and maintain effectiveness for at least four weeks of treatment.
Spravato is administered as a nasal spray and requires supervision from a healthcare provider in a clinical setting. Unlike other antidepressants that target serotonin and dopamine levels in the brain, Spravato operates by enhancing the levels of glutamate, the most prevalent neurotransmitter in the brain, facilitating communication between neurons.
In a recent report, Johnson & Johnson noted that sales of Spravato surged by 60% to $271 million for the quarter ending June 30, compared to the same period in 2023. The medication has been utilized by 100,000 individuals across 77 countries.