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, so it can be used as a standalone treatment for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients whose symptoms did not improve despite trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people worldwide living with major depressive disorder suffer from 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 is supported by data from a late-stage clinical trial indicating that Spravato can alleviate symptoms in patients as soon as 24 hours after treatment and maintain improvements for a minimum of four weeks.
Spravato is administered as a nasal spray and is required to be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that primarily affect serotonin and dopamine levels in the brain, Spravato functions by enhancing glutamate levels, the most prevalent neurotransmitter, facilitating communication between neurons.
Sales of Spravato increased by 60%, reaching $271 million in the three months ending June 30, compared to the same period in 2022. According to Johnson & Johnson, the treatment has been utilized by 100,000 individuals across 77 countries.