Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based drug, Spravato, as a standalone therapy for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was authorized for use alongside an oral antidepressant for patients whose symptoms failed to improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, the 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 FDA application is supported by data from a late-stage clinical trial indicating that Spravato, when used alone, was effective in alleviating patients’ symptoms as early as 24 hours after treatment, maintaining its efficacy for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that work by regulating neurotransmitters such as serotonin and dopamine, Spravato enhances the activity of glutamate, the brain’s most prevalent neurotransmitter, facilitating communication between neurons.
Sales of Spravato experienced a significant increase of 60%, reaching $271 million in the quarter ending June 30, compared to the same timeframe in 2022. Johnson & Johnson reported that the drug has been utilized by 100,000 patients across 77 countries.