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, as a standalone therapy for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designated for use alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals globally suffering from major depressive disorder experience treatment-resistant depression.
“Many patients struggling with difficult-to-treat depression spend an excessive amount of time trying multiple treatments that fail to alleviate their symptoms, leading to considerable emotional and functional strain for both them and their loved ones,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The submission was supported by data from a late-stage clinical trial, which demonstrated that Spravato, when used as a standalone treatment, alleviated patients’ symptoms as early as 24 hours after administration, maintaining effects for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that affect neurotransmitters like serotonin and dopamine, Spravato enhances the function of glutamate in the brain, which is the most prevalent neurotransmitter and essential for neuronal communication.
Sales of Spravato increased by 60%, reaching $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.