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, as a standalone treatment for patients with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for individuals whose symptoms did not improve after trying two or more antidepressants.
The company reported that nearly 30 percent of the estimated 280 million people globally who suffer from major depressive disorder have treatment-resistant depression. Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized in a press release that many patients struggling with difficult-to-treat depression often spend excessive time trying various treatments that fail to alleviate their symptoms, leading to significant emotional and functional challenges for both patients and their families.
This application to the FDA was supported by data from a late-stage clinical trial indicating that Spravato, when used alone, began to alleviate symptoms within 24 hours and continued to do so for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike other antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter and plays a vital role in facilitating communication between neurons.
Sales of Spravato surged by 60%, reaching $271 million in the three months ending June 30, compared to the same period in 2022. Johnson & Johnson reported that the medication has been utilized by 100,000 individuals across 77 countries.