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, seeking to allow its use as a standalone therapy for treatment-resistant depression.
In previous approvals, Spravato was sanctioned in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide who suffer from major depressive disorder are affected by treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated, “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 recent application includes results from a late-stage clinical trial that indicated Spravato, when used as a standalone treatment, could alleviate symptoms as soon as 24 hours after administration and maintain that relief for at least four weeks.
Spravato is delivered as a nasal spray and must be taken under the monitoring of a healthcare professional in a clinical setting. Unlike traditional antidepressants that modulate brain chemicals such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter and facilitates communication between neurons.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30 compared to the same period in 2023. Johnson & Johnson reported that the medication has been utilized by 100,000 patients across 77 countries.