Johnson & Johnson announced on Monday that it has submitted a proposal to the U.S. Food and Drug Administration (FDA) to widen the usage of its ketamine-derived medication, Spravato, allowing it to be used as a standalone treatment for individuals suffering from treatment-resistant depression.
Initially approved in 2019, Spravato was authorized for use alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more different antidepressants. According to Johnson & Johnson, nearly 30% of the approximately 280 million individuals globally diagnosed with major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, highlighted the struggles many patients face, stating, “Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones.”
The application was supported by results from a late-stage clinical trial, indicating that Spravato, when used as a standalone therapy, showed positive effects in alleviating symptoms within 24 hours and continued to do so for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of healthcare professionals. Unlike conventional antidepressants that primarily target neurotransmitters like serotonin and dopamine, Spravato enhances the activity of glutamate in the brain, a key neurotransmitter that facilitates communication between neurons.
The drug has seen a notable increase in sales, with a 60% jump, reaching $271 million in the second quarter of 2023 compared to the same period last year. Spravato has been utilized by over 100,000 patients across 77 countries.
This move could bring new hope to many who struggle with treatment-resistant depression, providing an alternative option that may offer faster relief and improve overall quality of life.
As the medical community continues to explore effective treatments for mental health disorders, innovations like Spravato’s proposed standalone usage could signify a positive turning point in addressing the needs of patients who have faced limited options.