Johnson & Johnson announced on Monday that it has applied to the U.S. Food and Drug Administration (FDA) to expand 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 initially intended to be used in conjunction with an oral antidepressant for patients who did not respond to two or more previous antidepressants. The company noted that nearly 30 percent of the approximately 280 million people globally diagnosed with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release that many patients struggle to find effective treatments, often cycling through numerous options that fail to alleviate their symptoms, leading to significant emotional and functional challenges for them and their families.
The application submitted to the FDA included data from a late-stage clinical trial which indicated that Spravato, when used alone, began to reduce patient symptoms as quickly as 24 hours after administration and continued to do so for at least a month.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a clinical environment. Unlike traditional antidepressants that target chemicals such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is essential for neuronal communication.
Sales of Spravato experienced a significant increase of 60%, reaching $271 million in the quarter ending June 30, compared to the same time last year. The drug has been prescribed to 100,000 individuals across 77 countries, according to Johnson & Johnson.