Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based medication, Spravato, to function as a standalone treatment for patients with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designed to be used in conjunction with an oral antidepressant for those whose symptoms did not respond to two or more traditional antidepressant medications.
The company highlighted that nearly 30 percent of the estimated 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression. Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release the need for effective treatment options, noting the significant emotional and functional burdens that these patients and their families face during lengthy treatment cycles that fail to alleviate symptoms.
The application to the FDA was supported by data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone therapy, could begin alleviating symptoms within 24 hours and maintain effectiveness for at least four weeks.
Spravato is delivered via nasal spray and must be administered in a healthcare setting under the supervision of a healthcare professional. In contrast to conventional antidepressants that affect neurotransmitters like serotonin and dopamine, Spravato increases glutamate levels in the brain, which is the most prevalent neurotransmitter and is essential for neuronal communication.
Sales of Spravato surged by 60% to $271 million during the quarter ending June 30 compared to the same period in the previous year. The medication has been utilized by 100,000 patients across 77 countries, as reported by Johnson & Johnson.