Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based medication, Spravato, as an independent treatment for resistant depression.
Spravato was initially approved by the FDA in 2019, but only 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 globally diagnosed 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 submitted to the FDA included data from a late-stage clinical trial indicating that Spravato, used as a standalone treatment, was effective in alleviating patients’ symptoms as early as 24 hours post-treatment and maintained this effect for at least four weeks.
Spravato is delivered via a nasal spray and must be administered in a healthcare setting under the supervision of a healthcare professional. In contrast to traditional antidepressants that typically affect neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter and plays a critical role in neuronal communication.
Sales of Spravato surged by 60% to $271 million during the three-month period ending June 30, compared to the same quarter in 2023. The medication has been utilized by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.