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, allowing it to be administered as a standalone treatment for individuals suffering from treatment-resistant depression.
The FDA initially granted approval for Spravato in 2019, permitting its use alongside an oral antidepressant for patients who had not found relief after trying two or more antidepressants.
Johnson & Johnson highlighted that nearly 30 percent of the approximately 280 million people worldwide affected by 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 application for expanded use was supported by data from a late-stage clinical trial indicating that Spravato, when used alone, could alleviate symptoms in patients as soon as 24 hours after treatment, sustaining benefits for at least four weeks.
Spravato is delivered via nasal spray and must be administered under the supervision of a healthcare provider in a clinical environment. Unlike traditional antidepressants that target chemicals such as serotonin and dopamine, Spravato increases levels of glutamate, the brain’s most abundant neurotransmitter, which facilitates communication between neurons.
Sales of Spravato surged by 60% to $271 million in the second quarter compared to the same period in 2023. According to Johnson & Johnson, the medication has been utilized by 100,000 individuals across 77 countries.