Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based drug, Spravato, allowing it to be utilized as a standalone therapy for treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was designed to be used in conjunction with oral antidepressants for patients who did not find relief from two or more antidepressants. Johnson & Johnson noted that nearly 30 percent of the estimated 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the struggles faced by patients suffering from difficult-to-treat depression, explaining that many endure prolonged periods of trying various treatments with little success, resulting in significant emotional and functional strain on both patients and their families.
The new application includes data from a late-stage clinical trial demonstrating that Spravato can effectively alleviate symptoms in patients as quickly as 24 hours after administration, maintaining its effects for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a clinical environment. Unlike traditional antidepressants that influence neurotransmitters like serotonin and dopamine, Spravato enhances glutamate activity in the brain, which is the most common neurotransmitter and facilitates communication between neurons.
Sales of Spravato increased by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in the previous year. The drug has been used by approximately 100,000 individuals across 77 countries, as reported by Johnson & Johnson.