Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based drug, Spravato, allowing it to be used as a standalone treatment for patients with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019, but only in combination with an oral antidepressant for individuals whose symptoms did not respond to two or more antidepressant therapies. According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals globally suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, expressed in a press release that “many patients dealing with difficult-to-treat depression endure prolonged periods of trying multiple treatments that fail to effectively alleviate their symptoms, leading to substantial functional and emotional strain on themselves and their families.”
The application for expanded use includes findings from a late-stage clinical trial demonstrating that Spravato, when administered alone, significantly alleviated patients’ symptoms as soon as 24 hours after treatment and continued to be effective for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a medical setting. Unlike traditional antidepressants that target serotonin and dopamine levels in the brain, Spravato operates by enhancing glutamate, the brain’s most abundant neurotransmitter, which facilitates communication among neurons.
Sales of Spravato have increased dramatically, rising 60% to $271 million in the quarter ending June 30 compared to the same timeframe in 2023. The drug has been utilized by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.