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) seeking to expand the use of its ketamine-based drug, Spravato, as a standalone treatment for individuals suffering from treatment-resistant depression.

Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms had not improved with two or more antidepressant medications.

According to Johnson & Johnson, 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, highlighted that many patients with difficult-to-treat depression often go through multiple ineffective treatments for extended periods, leading to significant emotional and functional burdens for both patients and their families.

The FDA application includes data from a late-stage clinical trial indicating that Spravato, when used alone, alleviated patients’ symptoms as soon as 24 hours after administration and maintained effectiveness for at least four weeks.

Spravato is administered as a nasal spray and must be given under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that target brain chemicals like serotonin and dopamine, Spravato enhances glutamate activity, the most prevalent neurotransmitter in the brain, facilitating communication between neurons.

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

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