Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to broaden the approved use of its ketamine-based medication, Spravato, so that it can be utilized as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 to be used in conjunction with an oral antidepressant for patients whose symptoms failed to improve after trying two or more different antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
“Many patients facing difficult-to-treat depression spend too much time going through various treatments that do not effectively alleviate their symptoms. This situation can place a substantial emotional and functional burden on both the patients and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application for expanded use is backed by data from a late-stage clinical trial indicating that Spravato, when used as a standalone therapy, can alleviate patients’ symptoms as soon as 24 hours after treatment and maintain symptom relief for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare provider in a medical setting. Unlike conventional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato functions by increasing levels of glutamate in the brain. Glutamate, the most prevalent neurotransmitter, facilitates communication between neurons.
Sales of Spravato increased by 60% to $271 million in the three months ending June 30, compared to the same time frame in 2023. According to Johnson & Johnson, the medication has been utilized by 100,000 individuals across 77 countries.