Johnson & Johnson Seeks FDA Approval for New Use of Breakthrough Depression Treatment

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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, as a standalone treatment for individuals with treatment-resistant depression.

Originally approved by the FDA in 2019, Spravato was initially intended to be used alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants.

According to Johnson & Johnson, nearly 30% of the approximately 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression.

Bill Martin, head of neuroscience at Johnson & Johnson, stated 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.”

The application includes findings from a late-stage clinical trial indicating that Spravato, when used as a single treatment, alleviated patients’ symptoms as soon as 24 hours after administration and remained effective for at least four weeks.

Spravato is delivered as a nasal spray and requires administration under the supervision of a healthcare professional in a medical setting. Unlike traditional antidepressants that primarily target chemicals like serotonin and dopamine, Spravato enhances the activity of glutamate in the brain, which is the most prevalent neurotransmitter and is essential for neuronal communication.

Sales of Spravato surged by 60% to $271 million in the quarter ending June 30 compared to the same period in 2023. The medication has been utilized by approximately 100,000 patients across 77 countries, as reported by Johnson & Johnson.

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