Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based drug, Spravato, so that it can be utilized as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the 280 million people globally who suffer from 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 to the FDA includes data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone treatment, can alleviate symptoms in patients as quickly as 24 hours after administration and maintain effectiveness for at least four weeks.
Spravato is administered via a nasal spray and has to be taken under the supervision of a healthcare provider in a medical setting. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, which is the most prevalent neurotransmitter and plays a vital role in neuronal communication.
Sales of Spravato surged by 60% to $271 million for the quarter ending June 30, compared to the same period in 2023. The drug has been used by approximately 100,000 patients across 77 countries, as reported by Johnson & Johnson.