Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, as a standalone treatment for individuals suffering from treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was authorized for use in conjunction with an oral antidepressant for patients whose depression symptoms did not improve after trying two or more other antidepressants. Johnson & Johnson has reported that nearly 30 percent of the 280 million individuals globally affected by major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the challenges that patients face when dealing with difficult-to-treat depression, stating that many endure extended periods of ineffective treatments, which can lead to significant emotional and functional challenges for both patients and their families.
The application to the FDA includes data from a late-stage clinical trial, which indicated that Spravato, when used alone, could alleviate symptoms in patients as soon as 24 hours post-treatment and maintain those improvements for at least four weeks.
Spravato is administered through a nasal spray and must be used 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 enhances the activity of glutamate, the most prevalent neurotransmitter, facilitating better communication between neurons.
Sales for Spravato saw a remarkable increase of 60%, reaching $271 million in the quarter ending June 30 compared to the same period the previous year. According to Johnson & Johnson, Spravato has been utilized by approximately 100,000 individuals across 77 countries.