Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) for approval to expand the use of its ketamine-based drug, Spravato, to be utilized as a standalone treatment for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was authorized for use in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression.
“Many patients facing difficult-to-treat depression often spend extended periods trying multiple treatments that fail to effectively alleviate their symptoms, resulting in significant functional and emotional burdens for both patients and their families,” remarked Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application was supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, could alleviate symptoms as soon as 24 hours after administration and continue to do so for at least four weeks.
Spravato is delivered via nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato operates by enhancing levels of glutamate, which is the most abundant neurotransmitter in the brain and plays a critical role in neuron communication.
Sales of Spravato experienced a significant increase of 60%, reaching $271 million for the three months ending June 30, compared to the same timeframe in 2022. According to Johnson & Johnson, the drug has been used by 100,000 individuals across 77 countries.