Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) seeking to broaden the approved use of its ketamine-based medication, Spravato, as a standalone therapy for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was authorized for use in conjunction with an oral antidepressant for patients who did not respond to two or more alternative treatments.
Johnson & Johnson highlighted that nearly 30 percent of the approximately 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release that many patients dealing with difficult-to-treat depression often spend extensive time trying various treatments that fail to alleviate their symptoms, resulting in significant emotional and functional challenges for both the patients and their families.
The application to the FDA includes results from a late-stage clinical trial indicating that Spravato, when administered alone, was effective in alleviating symptoms as quickly as 24 hours after treatment and maintained efficacy for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a medical environment. Unlike traditional antidepressants that typically target serotonin and dopamine, Spravato enhances glutamate activity in the brain, which is the most prevalent neurotransmitter and plays a crucial role in neuron communication.
In the second quarter of this year, sales of Spravato surged by 60%, reaching $271 million compared to the same period in 2023. The medication has already been utilized by 100,000 patients across 77 countries, according to Johnson & Johnson’s report.