Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based drug, Spravato, allowing it to be used as a standalone treatment for individuals with treatment-resistant depression.
Spravato received FDA approval in 2019 for use alongside oral antidepressants in patients whose symptoms did not improve after trying two or more antidepressant medications. Johnson & Johnson highlighted that nearly 30 percent of the approximately 280 million individuals worldwide suffering from major depressive disorder are affected by treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release the challenges faced by patients dealing with difficult-to-treat depression and the emotional toll it can take on them and their families. He noted that many patients often go through lengthy periods trying various treatments without success.
The recent application is supported by data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone therapy, can alleviate symptoms for some patients as quickly as 24 hours after administration, with effects lasting for at least four weeks.
Spravato is administered as a nasal spray and must be given under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that primarily affect serotonin and dopamine levels in the brain, Spravato operates by increasing glutamate, the brain’s most prevalent neurotransmitter that facilitates communication between neurons.
In financial terms, Spravato sales surged by 60% to $271 million in the quarter ending June 30, compared to the same quarter in 2023. Johnson & Johnson reports that the drug has been utilized by approximately 100,000 patients across 77 countries.