J&J Seeks FDA Approval for Standalone Ketamine Drug to Combat Depression

Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) seeking to broaden the use of its ketamine-based drug, Spravato, to function as a standalone therapy for treatment-resistant depression.

The FDA initially approved Spravato in 2019 for use alongside an oral antidepressant in patients whose symptoms did not improve after trying two or more antidepressants. Johnson & Johnson noted that close to 30 percent of the 280 million individuals worldwide affected by major depressive disorder experience treatment-resistant depression.

Bill Martin, head of neuroscience at Johnson & Johnson, remarked in a press release, “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.”

This application is supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, alleviated patients’ symptoms as quickly as 24 hours post-treatment and maintained effectiveness 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 traditional antidepressants that adjust levels of serotonin and dopamine in the brain, Spravato enhances the action of glutamate, the brain’s 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. The drug has been utilized by 100,000 patients across 77 countries, according to Johnson & Johnson.

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