Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based drug, Spravato, as a standalone treatment for resistant depression.
Spravato was initially approved by the FDA in 2019 for use with an oral antidepressant, specifically for patients whose symptoms did not improve after trying two or more other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression.
“As many patients struggle with difficult-to-treat depression, they often spend excessive time trying various treatments that fail to alleviate their symptoms, resulting in significant emotional and functional challenges for them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application submitted includes findings from a late-stage clinical trial, which demonstrated that Spravato, when used as a standalone treatment, can alleviate symptoms as soon as 24 hours after administration and continues 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 professional in a clinical setting. Unlike other antidepressants that aim to regulate neurotransmitters like serotonin and dopamine, Spravato operates by enhancing glutamate levels in the brain, which is the most prevalent neurotransmitter and facilitates communication between neurons.
Sales of Spravato surged by 60%, reaching $271 million in the three months ending June 30, compared to the same timeframe in 2023. The medication has been utilized by over 100,000 individuals across 77 countries, as reported by Johnson & Johnson.