Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, as a standalone treatment for individuals suffering from treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients who had not seen improvements after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people worldwide who have major depressive disorder experience treatment-resistant depression. Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release that many patients endure prolonged periods trying various treatments that fail to alleviate their symptoms, placing a significant emotional and functional strain on both patients and their families.
The company’s application is supported by data from a late-stage clinical trial that indicated Spravato, when used as a standalone treatment, began to alleviate symptoms as quickly as 24 hours after administration and maintained effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be taken under medical supervision in a healthcare facility. Unlike traditional antidepressants that typically affect serotonin and dopamine levels, Spravato enhances the action of glutamate, the brain’s most prevalent neurotransmitter, facilitating communication between neurons.
Sales of Spravato rose by 60% to $271 million for the quarter ending on June 30, compared to the same period in 2023. The medication has been administered to 100,000 individuals across 77 countries, as reported by Johnson & Johnson.