Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, so that it can be utilized as a standalone therapy for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was sanctioned for use in conjunction with an oral antidepressant for patients whose symptoms had not improved after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals globally living with major depressive disorder experience treatment-resistant depression.
“Numerous patients dealing with hard-to-treat depression often endure prolonged periods cycling through various treatments that fail to alleviate their symptoms, leading to considerable functional and emotional strain on both patients and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application included results from a late-stage clinical trial which indicated that Spravato, when used as a standalone treatment, alleviated symptoms in patients as quickly as 24 hours after administration, with effects lasting at least four weeks.
Spravato is delivered via nasal spray and must be administered under the supervision of a healthcare professional in a medical environment. Unlike traditional antidepressants that adjust chemicals such as serotonin and dopamine in the brain, Spravato enhances glutamate activity. Glutamate, being the most prevalent neurotransmitter in the brain, facilitates communication between neurons.
Sales figures for Spravato surged by 60% to reach $271 million in the three months ending June 30, compared to the same timeframe in 2023. Johnson & Johnson reported that the medication has been used by 100,000 individuals across 77 countries.