Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based drug, Spravato, to be utilized as a standalone therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with 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 approximately 280 million individuals worldwide who suffer 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 application for Spravato’s expanded use includes data from a late-stage clinical trial indicating that the drug, when used alone, started to alleviate patients’ symptoms as quickly as 24 hours after treatment and sustained improvement for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare provider within a healthcare setting. Unlike typical antidepressants that modify neurotransmitters such as serotonin and dopamine, Spravato operates by increasing levels of glutamate in the brain, which is the most prevalent neurotransmitter and plays a crucial role in neuronal communication.
Sales of Spravato increased by 60 percent to $271 million for the quarter ending June 30, compared to the same period in 2023. The drug has been prescribed to 100,000 patients across 77 countries, as reported by Johnson & Johnson.