Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved usage of its ketamine-derived medication, Spravato, for use as a standalone therapy in treating resistant depression.
Initially approved by the FDA in 2019, Spravato was designated for use in conjunction with an oral antidepressant for patients whose symptoms failed to improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
“Many patients facing difficult-to-treat depression endure prolonged periods trying out various treatments that fail to alleviate their symptoms, which can create a significant emotional and functional strain on both patients and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The company submitted its application with findings from a late-stage clinical trial demonstrating that Spravato, when used as a standalone treatment, can alleviate patient symptoms as early as 24 hours after administration and can continue to do so 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 setting. In contrast to other antidepressants that target neurotransmitters like serotonin and dopamine, Spravato increases glutamate levels in the brain, which facilitates communication between neurons.
Sales of Spravato surged by 60%, reaching $271 million in the three months ending June 30, compared to the same period in 2023. The medication has been utilized by 100,000 individuals across 77 countries, according to Johnson & Johnson.