J&J Seeks FDA Nod for Standalone Ketamine Breakthrough in 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 expand the approved use of its ketamine-based drug, Spravato, allowing it to be prescribed as a standalone treatment for individuals suffering from treatment-resistant depression.

The FDA originally approved Spravato in 2019, but only for use in conjunction with an oral antidepressant for patients who did not see improvements after trying two or more antidepressant medications.

Johnson & Johnson highlighted that nearly 30% of the approximately 280 million people worldwide diagnosed with major depressive disorder experience treatment-resistant depression.

Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press statement that many patients with difficult-to-treat depression often spend excessive time switching through various treatments that fail to alleviate their symptoms, leading to considerable emotional and functional stress for both the patients and their families.

The application for expanded use is backed by data from a late-stage clinical trial, which indicated that Spravato could alleviate patients’ depression symptoms within 24 hours of administration and continue to be effective for at least four weeks.

Spravato is delivered as a nasal spray and is required to be taken under the observation of a healthcare professional in a clinical setting. Unlike traditional antidepressants that primarily alter serotonin and dopamine levels, Spravato functions by increasing glutamate in the brain, which is the most prevalent neurotransmitter and is essential for communication between neurons.

Sales for Spravato surged by 60%, reaching $271 million for the quarter ending June 30, compared to the same quarter in 2023. As reported by Johnson & Johnson, the drug has been administered to 100,000 patients across 77 countries.

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