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-derived medication, Spravato, allowing it to be utilized as a standalone therapy for patients with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant, specifically for those whose symptoms did not improve after trying two or more antidepressants. According to Johnson & Johnson, nearly 30 percent of the 280 million individuals worldwide who suffer from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, commented 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 for standalone use was supported by data from a late-stage clinical trial, which indicated that Spravato helped alleviate patients’ symptoms as soon 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 professional supervision in a medical setting. Unlike typical antidepressants that affect neurotransmitters like serotonin and dopamine, Spravato increases levels of glutamate, the most prevalent neurotransmitter in the brain, facilitating neuronal communication.
In a recent financial disclosure, Johnson & Johnson reported that sales of Spravato surged by 60% to $271 million for the quarter ending June 30, compared to the same period in the previous year. The medication has been administered to 100,000 individuals across 77 countries.