J&J Seeks FDA Approval for Standalone Treatment of Treatment-Resistant Depression with Spravato

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 medication, Spravato, to function as a standalone treatment for individuals with treatment-resistant depression.

Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients who did not see improvement after trying two or more antidepressants.

According to Johnson & Johnson, nearly 30 percent of the approximate 280 million people suffering from major depressive disorder experience treatment-resistant depression. Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized in a press release that many patients endure extended periods trying multiple ineffective treatments, leading to significant emotional and functional challenges for both them and their families.

The request is supported by data from a late-stage clinical trial indicating that Spravato can alleviate symptoms as soon as 24 hours post-treatment and continue to provide relief for at least four weeks.

Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that alter neurotransmitters like serotonin and dopamine, Spravato increases glutamate levels in the brain, which is crucial for neuronal communication.

Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same timeframe in 2023. The drug has been utilized by approximately 100,000 individuals across 77 countries, according to Johnson & Johnson.

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