Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approval of its ketamine-based medication, Spravato, 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 conditions did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the 280 million individuals worldwide diagnosed with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated that “many patients dealing with hard-to-treat depression endure lengthy periods trying various treatments that fail to effectively alleviate their symptoms, imposing a considerable emotional and functional burden on both patients and their families.”
The application to the FDA was supported by data from a late-stage clinical trial demonstrating that Spravato, when used alone, alleviated symptoms in patients as quickly as 24 hours after administration and maintained its effects for at least four weeks.
Spravato is delivered as a nasal spray and is required to be administered in a healthcare setting under the supervision of a healthcare provider. Unlike traditional antidepressants that primarily adjust neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter and essential for neuronal communication.
Sales of Spravato surged by 60% to $271 million in the three months ending June 30 compared to the same period in 2023. Johnson & Johnson reported that the medication has been administered to 100,000 patients across 77 countries.