Johnson & Johnson announced on Monday that it has applied to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 to be used alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, approximately 30 percent of the estimated 280 million individuals worldwide with major depressive disorder suffer from treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release that “many patients struggling with difficult-to-treat depression endure lengthy periods trying various treatments that fail to alleviate their symptoms, significantly impacting their functional and emotional wellbeing.”
The application to the FDA included data from a late-stage clinical trial, demonstrating that Spravato, when used as a standalone treatment, can relieve symptoms as quickly as 24 hours after administration and for at least four weeks of continued treatment.
Spravato is delivered through a nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that target serotonin and dopamine levels in the brain, Spravato operates by increasing glutamate levels. Glutamate is the most prevalent neurotransmitter, facilitating communication between neurons.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. To date, Spravato has been utilized by over 100,000 individuals across 77 countries, as reported by Johnson & Johnson.