Johnson & Johnson Seeks FDA Approval for Standalone Depression Treatment

Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based drug, Spravato, for treatment-resistant depression as a standalone therapy.

Initially approved by the FDA in 2019, Spravato was authorized for use in combination with an oral antidepressant for patients whose symptoms did not improve after trying two or more other antidepressants. Johnson & Johnson highlighted that nearly 30 percent of the estimated 280 million people globally living with major depressive disorder experience treatment-resistant depression.

Bill Martin, head of neuroscience at Johnson & Johnson, emphasized that many patients struggling with difficult-to-treat depression often endure lengthy periods trying multiple treatments that fail to alleviate their symptoms, leading to significant emotional and functional challenges for both patients and their families.

The application submitted to the FDA included data from a late-stage clinical trial indicating that Spravato, used as a standalone treatment, began to relieve patients’ symptoms as soon as 24 hours after administration and continued to do so for at least four weeks.

Spravato is given as a nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that typically target neurotransmitters like serotonin and dopamine, Spravato increases levels of glutamate, the most abundant neurotransmitter in the brain, which facilitates communication between neurons.

Sales of Spravato experienced a remarkable increase of 60%, reaching $271 million in the quarter ending June 30 compared to the same period in 2022. The drug has been utilized by approximately 100,000 patients across 77 countries, as reported by Johnson & Johnson.

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