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 therapy for patients suffering from treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was authorized for use in conjunction with an oral antidepressant for patients whose depressive symptoms did not improve after trying two or more other antidepressants.
Johnson & Johnson noted that nearly 30 percent of the estimated 280 million individuals globally affected by major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, explained, “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 was supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, was effective in alleviating symptoms of depression as soon as 24 hours post-treatment and maintained benefits for at least four weeks.
Spravato is administered as a nasal spray and must be taken under medical supervision in a healthcare setting. Unlike conventional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter, facilitating communication between neurons.
Sales for Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same quarter in the previous year. Johnson & Johnson reported that Spravato has been utilized by 100,000 patients across 77 countries.