Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone treatment for patients suffering from treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant in patients whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people worldwide with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated, “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 submission of the application included findings from a late-stage clinical trial indicating that Spravato, when used as a standalone therapy, began to alleviate patients’ symptoms as soon as 24 hours after treatment and continued to do so for at least four weeks.
Spravato is administered via a nasal spray and needs to be taken under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants, which primarily affect neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate activity in the brain, which is the most prevalent neurotransmitter and facilitates communication between neurons.
In terms of sales performance, Spravato saw a significant increase of 60%, reaching $271 million in the three months ending June 30, compared to the same period last year. Johnson & Johnson reports that Spravato has been utilized by 100,000 individuals across 77 countries.