Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant in 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 struggling with major depressive disorder are classified as having treatment-resistant depression.
“Many patients with difficult-to-treat depression end up going through multiple treatments that fail to alleviate their symptoms, resulting in significant emotional and functional challenges for both patients and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The company’s application includes data from a late-stage clinical trial indicating that Spravato, when used as a standalone therapy, alleviated patients’ symptoms as soon as 24 hours after administration and provided relief for at least four weeks.
Spravato is delivered via nasal spray and must be administered under the supervision of a healthcare professional in a clinical environment. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances glutamate activity in the brain. Glutamate is the brain’s most abundant neurotransmitter, crucial for neuronal communication.
Sales of Spravato surged by 60% to $271 million in the three months ending June 30, compared to the same timeframe in 2023. The medication has been utilized by 100,000 patients across 77 countries, according to Johnson & Johnson.