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 utilized as a standalone treatment for individuals with treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was initially designated for use in conjunction with an oral antidepressant for patients whose depressive symptoms have not improved despite trying two or more other antidepressants.
Johnson & Johnson noted that nearly 30 percent of the estimated 280 million people worldwide 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 a significant functional and emotional burden on patients and their loved ones.”
The application for expanded use is supported by data from a late-stage clinical trial, which indicated that Spravato, when administered as a standalone treatment, began to alleviate patients’ symptoms as quickly as 24 hours after treatment and continued to do so for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under healthcare professional supervision in a clinical setting. Unlike other antidepressants that primarily target chemicals such as serotonin and dopamine, Spravato enhances the activity of glutamate in the brain. Glutamate is the most prevalent neurotransmitter in the brain, facilitating communication between neurons.
Sales of Spravato surged by 60% to $271 million in the three months ending June 30, compared to the same timeframe in 2023. According to Johnson & Johnson, the treatment has been used by 100,000 individuals across 77 countries.