Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone treatment for individuals with treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was initially designed to be used in conjunction with an oral antidepressant for patients whose symptoms failed to improve after undergoing treatment with two or more antidepressants. Johnson & Johnson indicated 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, expressed in a press release that many patients enduring difficult-to-treat depression spend excessive time trying various treatments that do not adequately alleviate their symptoms, leading to significant emotional and functional challenges for both them and their families.
The application was backed by data from a late-stage clinical trial that revealed Spravato, when used as a standalone therapy, could significantly reduce symptoms in patients as soon as 24 hours after treatment, with effects lasting 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 target neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate is the most abundant neurotransmitter and plays a crucial role in neuronal communication.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. The medication has been utilized by 100,000 individuals across 77 countries, according to Johnson & Johnson.