Illustration of J&J Seeks FDA Approval for Revolutionary Depression Treatment

J&J Seeks FDA Approval for Revolutionary 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 medication, Spravato, allowing it to be utilized as a standalone treatment for resistant depression.

Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant, targeting patients whose symptoms did not improve after trying two or more other medications. According to Johnson & Johnson, close to 30% of the approximately 280 million people globally with major depressive disorder experience treatment-resistant depression.

Bill Martin, head of neuroscience at Johnson & Johnson, highlighted the struggles faced by patients with difficult-to-treat depression, noting that they often endure lengthy periods of trialing various treatments without relief, leading to significant emotional and functional challenges for both themselves and their families.

The application for increased use of Spravato was supported by late-stage clinical trial data indicating that patients experienced symptom relief as soon as 24 hours after treatment, with effects lasting for at least four weeks. Spravato is administered as a nasal spray under medical supervision. Unlike traditional antidepressants that regulate serotonin and dopamine, Spravato enhances glutamate activity in the brain, which is crucial for neuronal communication.

Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30 compared to the same period in 2023. To date, the medication has been utilized by approximately 100,000 individuals across 77 countries.

This development could represent a significant advancement in the treatment options available for individuals suffering from treatment-resistant depression, potentially providing new hope for those who have long struggled to find effective relief.

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