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 therapy for individuals with treatment-resistant depression.
Spravato received its initial FDA approval in 2019, but only for use in conjunction with an oral antidepressant for patients whose symptoms remained unresolved after trying two or more different antidepressants.
According to Johnson & Johnson, nearly 30% of the estimated 280 million people worldwide living with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release, “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 data from a late-stage clinical trial, which demonstrated that Spravato, when used as a standalone treatment, alleviated patients’ symptoms as early as 24 hours after administration and maintained efficacy 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. Unlike traditional antidepressants that typically target neurotransmitters like serotonin and dopamine, Spravato enhances the activity of glutamate in the brain, which is crucial for neuronal communication.
Sales of Spravato surged by 60% to $271 million in the three months ending June 30, compared to the same period last year. The drug has been administered to 100,000 patients across 77 countries, according to the company.