Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone treatment for patients with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms persisted despite trying two or more other antidepressants.
According to Johnson & Johnson, nearly 30% of the estimated 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients with difficult-to-treat depression. He noted that many endure prolonged periods of trying various treatments that fail to alleviate their symptoms, resulting in significant emotional distress for both patients and their families.
The application was supported by data from a late-stage clinical trial that indicated Spravato, when administered as a standalone treatment, could mitigate symptoms as quickly as 24 hours after administration and maintain these effects for at least four weeks.
Spravato is delivered as a nasal spray and must be used under the supervision of a healthcare provider. Unlike traditional antidepressants, which typically target chemicals like serotonin and dopamine in the brain, Spravato functions by increasing levels of glutamate, the most prevalent neurotransmitter, which facilitates communication between neurons.
Sales of Spravato surged by 60%, reaching $271 million during the three months ending June 30, compared to the same period in 2023. Johnson & Johnson reported that the drug has been employed by 100,000 individuals across 77 countries.