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-derived medication, Spravato, allowing it to be administered as a standalone treatment for individuals suffering from treatment-resistant depression.
Spravato was first 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. Johnson & Johnson highlighted that nearly 30 percent of the estimated 280 million people worldwide who have major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the struggles faced by patients with difficult-to-treat depression, stating that they often spend excessive time going through multiple ineffective treatments, which can lead to significant emotional and functional strain on both patients and their families.
The application was supported by findings from a late-stage clinical trial, which indicated that Spravato, used as a standalone therapy, alleviated patient symptoms within 24 hours and continued to do so for at least four weeks post-treatment.
Spravato is delivered as a nasal spray and is required to be administered under the supervision of a healthcare professional in an approved setting. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato increases levels of glutamate in the brain, which is the most prevalent neurotransmitter and critical for neuronal communication.
Sales of Spravato increased by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in the previous year. Johnson & Johnson reported that the drug has been used by approximately 100,000 patients across 77 countries.