Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) seeking approval to use its ketamine-based medication, Spravato, as a standalone treatment for patients suffering from treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was authorized for use in conjunction with an oral antidepressant for individuals whose depressive symptoms failed to improve despite trying two or more different antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression.
“Many patients with difficult-to-treat depression endure prolonged periods of trying multiple treatments that do not effectively alleviate their symptoms, leading to significant functional and emotional strain on themselves and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The recent application includes findings from a late-stage clinical trial indicating that Spravato, when used as an independent therapy, can alleviate symptoms in patients as soon as 24 hours after treatment and maintain effectiveness 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 clinical environment. Unlike traditional antidepressants that influence neurotransmitters like serotonin and dopamine, Spravato operates by enhancing levels of glutamate in the brain, which is crucial for neuronal communication.
Sales of Spravato surged by 60 percent to $271 million in the quarter ending June 30, compared to the same period in the previous year. The medication has been utilized by approximately 100,000 patients across 77 countries, as reported by Johnson & Johnson.