Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based drug, Spravato, as a standalone treatment for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 as a complementary treatment alongside an oral antidepressant for patients who did not respond to two or more antidepressant medications.
According to Johnson & Johnson, approximately 30 percent of the estimated 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
“Many patients suffering from difficult-to-treat depression often endure prolonged periods cycling through various treatments that fail to alleviate their symptoms, resulting in significant functional and emotional strain on both them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The new application is supported by findings from a late-stage clinical trial showing that Spravato, when used as a standalone treatment, can begin to reduce symptoms as early as 24 hours after administration and maintain effectiveness for at least four weeks.
Spravato is delivered via a nasal spray and must be administered under the supervision of a healthcare professional in a clinical environment. Unlike traditional antidepressants that affect serotonin and dopamine levels, Spravato operates by increasing glutamate levels in the brain, which is the most prevalent neurotransmitter and plays a crucial role in neuronal communication.
Sales for Spravato surged by 60%, reaching $271 million in the three months ending June 30, compared to the same time frame in 2023. The medication has been utilized by approximately 100,000 patients across 77 countries, according to the company’s reports.