Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based medication, Spravato, to be utilized as a standalone therapy for treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was initially designated for use in conjunction with an oral antidepressant for patients whose conditions did not improve despite trying two or more different antidepressants. Johnson & Johnson highlighted that nearly 30% of the 280 million people worldwide suffering from major depressive disorder are affected by treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the significant challenges faced by patients dealing with tough-to-treat depression. He noted that many endure lengthy trials of multiple therapies that fail to alleviate their symptoms, resulting in emotional and functional burdens for both the patients and their families.
The recent application is backed by data from a late-stage clinical trial, which indicated that Spravato, when used alone, can begin alleviating symptoms as early as 24 hours after administration and can continue to provide relief for at least four weeks. Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that target serotonin and dopamine levels, Spravato enhances glutamate activity in the brain, which is essential for neuronal communication.
Sales for Spravato have surged, rising 60% to $271 million in the quarter ending June 30, compared to the same period in the previous year. Since its introduction, Spravato has been utilized by 100,000 patients across 77 countries.
This development marks a hopeful advance in the treatment options for individuals suffering from severe depression, potentially paving the way for more effective therapies that can promptly address their needs. The increasing recognition of treatment-resistant depression and the expansion of innovative solutions like Spravato could significantly enhance the quality of life for many patients worldwide.