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 resistant depression.
Initially approved by the FDA in 2019, Spravato was authorized for use alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide who suffer from major depressive disorder experience treatment-resistant depression.
“Many patients dealing with difficult-to-treat depression endure prolonged periods cycling through various treatments that fail to alleviate their symptoms. This can impose a significant functional and emotional burden on both patients and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application included findings from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, demonstrated symptom relief for patients as quickly as 24 hours after administration and maintained this improvement for at least four weeks.
Spravato is delivered through a nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike conventional antidepressants that target serotonin and dopamine levels, Spravato enhances glutamate activity in the brain, which is the most prevalent neurotransmitter responsible for neuronal communication.
The sales for Spravato saw a significant increase of 60%, reaching $271 million in the quarter ending June 30, compared to the same timeframe in 2023. Johnson & Johnson reported that the medication has been prescribed to 100,000 patients across 77 countries.