Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) seeking approval to expand the use of its ketamine-based medication, Spravato, as a standalone treatment for resistant depression.
The FDA initially approved Spravato in 2019 for use alongside an oral antidepressant for patients whose symptoms failed to improve with at least two other antidepressants.
According to Johnson & Johnson, approximately 30 percent of the 280 million individuals globally who suffer from major depressive disorder experience treatment-resistant depression.
“Many patients dealing with difficult-to-treat depression often go through numerous treatments without significant improvement, leading to considerable functional and emotional strain for both them and their loved ones,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application includes findings from a late-stage clinical trial indicating that Spravato, when used alone, can alleviate patients’ symptoms as quickly as 24 hours after administration and can remain effective for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a clinical environment. Unlike traditional antidepressants that primarily affect brain chemicals such as serotonin and dopamine, Spravato functions by increasing glutamate levels in the brain, a crucial neurotransmitter that facilitates communication between neurons.
Sales of Spravato surged by 60% to $271 million in the three months ending June 30, compared to the same period in 2022. Johnson & Johnson reported that Spravato has been utilized by 100,000 individuals across 77 countries.