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, allowing it to be used as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant in patients whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people worldwide suffering from major depressive disorder are affected by treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients with difficult-to-treat depression, noting that many spend extensive time cycling through various treatments without seeing improvement, which inflicts significant emotional and functional distress on both patients and their families.
The application includes data from a late-stage clinical trial demonstrating that Spravato, as a standalone treatment, provided symptom relief as quickly as 24 hours after administration and maintained efficacy for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that target chemicals such as serotonin and dopamine, Spravato operates by enhancing glutamate levels in the brain, which is the most prevalent neurotransmitter and essential for neuronal communication.
Sales of Spravato saw a remarkable 60% increase, reaching $271 million in the three months ending June 30, compared to the same period last year. The medication has been utilized by over 100,000 individuals across 77 countries, as reported by Johnson & Johnson.