Johnson & Johnson announced on Monday that it has submitted a new application to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based medication, Spravato. The company aims for the drug to be approved as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant, specifically for patients whose symptoms did not improve after trying two or more other antidepressants. Johnson & Johnson reported that around 30 percent of the approximately 280 million people globally with major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized the difficulties faced by patients who struggle with depression that does not respond to available treatments. He stated that this often leads to prolonged suffering and challenges for both patients and their families.
The application to the FDA is supported by data from a late-stage clinical trial, which indicated that Spravato as a standalone treatment could alleviate symptoms within 24 hours and maintain its effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be used under the supervision of a healthcare professional in a clinical environment. Unlike traditional antidepressants that typically adjust levels of serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, which is the most prevalent neurotransmitter and plays a crucial role in neuronal communication.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in the previous year. The drug has been utilized by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.