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, allowing it to be used as a standalone treatment for individuals with treatment-resistant depression.
Spravato received initial FDA approval in 2019 for use in conjunction with an oral antidepressant for patients whose depressive symptoms did not improve after trying two or more antidepressants.
Johnson & Johnson highlighted that nearly 30 percent of the approximately 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression.
“Many patients dealing with difficult-to-treat depression often spend excessive time trying various treatments that fail to alleviate their symptoms, which places a substantial functional and emotional burden on both patients and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application is supported by data from a late-stage clinical trial indicating that Spravato, when administered as a standalone therapy, can begin alleviating symptoms as quickly as 24 hours after treatment 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 medical setting. Unlike conventional antidepressants that affect brain chemicals such as serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter, facilitating communication between neurons.
Sales of Spravato surged 60% to $271 million in the second quarter ended June 30, compared to the same period in 2023. According to Johnson & Johnson, the drug has been utilized by 100,000 patients across 77 countries.