Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the approved use of its ketamine-based drug, Spravato, to be utilized as a standalone therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients who did not see improvement after trying two or more antidepressants. Johnson & Johnson highlighted that nearly 30 percent of the estimated 280 million individuals suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated that many patients with hard-to-treat depression endure lengthy periods trying various treatments that fail to alleviate their symptoms, resulting in significant emotional tolls on both patients and their families.
This application is supported by data from a late-stage clinical trial, which indicated that Spravato, when used alone, could improve patients’ symptoms within 24 hours of treatment and maintain that effect for at least four weeks.
Spravato is administered via nasal spray and requires supervision by a healthcare provider in a clinical setting. Unlike traditional antidepressants that target brain chemicals such as serotonin and dopamine, Spravato enhances glutamate activity in the brain, the most prevalent neurotransmitter, aiding neuronal communication.
Sales figures for Spravato show a significant increase of 60%, reaching $271 million for the quarter ending June 30 compared to the same period in 2023. The drug has been used by 100,000 patients across 77 countries, according to Johnson & Johnson.