Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, so that it can be utilized as a standalone therapy for treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was authorized for use alongside an oral antidepressant for patients whose condition did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
“Many patients dealing with difficult-to-treat depression often endure prolonged periods attempting various treatments that fail to alleviate their symptoms, resulting in significant emotional and functional challenges for both them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application to the FDA includes findings from a late-stage clinical trial that indicated Spravato, when used as a standalone treatment, was effective in relieving symptoms within 24 hours of administration and continued to do so for a minimum of four weeks.
Spravato is administered as a nasal spray and must be taken in a healthcare setting under the supervision of a healthcare provider. In contrast to other antidepressants that adjust brain chemicals like serotonin and dopamine, Spravato increases the levels of glutamate in the brain, which is the most prevalent neurotransmitter and essential for neuron communication.
In terms of sales, Spravato experienced a significant increase, with revenues rising 60% to $271 million for the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson reported that Spravato has been used by 100,000 patients across 77 countries.