Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, allowing it to be administered as a standalone therapy for individuals with treatment-resistant depression.
Spravato was first approved by the FDA in 2019 to be used alongside an oral antidepressant for patients whose symptoms failed to improve after trying two or more different antidepressants. The company highlighted that nearly 30 percent of the estimated 280 million people worldwide living with major depressive disorder experience treatment-resistant depression.
“Many patients struggling with difficult-to-treat depression spend a lengthy period navigating through various treatments that do not effectively alleviate their symptoms, which can place a significant emotional and functional strain on both patients and their families,” said Bill Martin, head of neuroscience at Johnson & Johnson, in a press statement.
The application to the FDA was supported by findings from a late-stage clinical trial, which demonstrated that Spravato, when used as a standalone treatment, could alleviate patients’ symptoms as soon as 24 hours after administration and continue to be effective for at least four weeks.
Spravato is administered through a nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike other antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances the activity of glutamate in the brain. Glutamate is the most prevalent neurotransmitter and plays a crucial role in facilitating communication between neurons.
In the second quarter, sales of Spravato surged by 60% to $271 million compared to the same period in 2023. According to Johnson & Johnson, Spravato has been utilized by 100,000 patients across 77 countries.