Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based medication, Spravato. The proposed expansion would allow Spravato to be used as a standalone treatment for individuals suffering from treatment-resistant depression.
Spravato was initially approved by the FDA in 2019, intended for use alongside an oral antidepressant for patients whose depression had not improved after trying two or more antidepressant medications.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people globally who have major depressive disorder experience treatment-resistant depression. Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the struggles faced by patients, stating that many spend excessively long periods trying various treatments that fail to alleviate their symptoms, placing a considerable emotional and functional strain on both patients and their families.
The new application is supported by data from a late-stage clinical trial indicating that Spravato, when administered alone, can begin to relieve patients’ symptoms as quickly as 24 hours after treatment and continue to provide relief 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 target neurotransmitters such as serotonin and dopamine, Spravato operates by enhancing glutamate activity in the brain. Glutamate is the most prevalent neurotransmitter and plays a critical role in neuronal communication.
Sales of Spravato have seen a significant boost, rising 60% to $271 million in the three months ending June 30, compared to the same period last year. The medication has been utilized by approximately 100,000 individuals across 77 countries, according to Johnson & Johnson.