Johnson & Johnson announced on Monday that it has submitted a proposal to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based drug, Spravato, allowing it to be used as a standalone treatment for resistant depression.
Spravato was first approved by the FDA in 2019, but only for use in conjunction with an oral antidepressant for patients who did not see improvement after trying two or more antidepressants. According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release that many patients endure long periods of trying various treatments with little success, significantly impacting their daily lives and relationships.
The application includes findings from a late-stage clinical trial that indicated Spravato, when used as a standalone therapy, could alleviate symptoms in patients within just 24 hours, with effects lasting at least four weeks after treatment.
Spravato is delivered as a nasal spray and must be administered under healthcare supervision. Unlike traditional antidepressants that target serotonin and dopamine levels, Spravato enhances glutamate activity in the brain. Glutamate, the brain’s most plentiful neurotransmitter, plays a crucial role in neuronal communication.
Sales for 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 patients across 77 countries, according to the company.