J&J Seeks FDA Approval for Standalone Spravato in Depression Battle

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

Initially approved by the FDA in 2019, Spravato was designed to be used in conjunction with an oral antidepressant for patients who did not see improvement after trying two or more different antidepressants. Johnson & Johnson noted that approximately 30 percent of the 280 million individuals globally who suffer from major depressive disorder experience treatment-resistant depression.

Bill Martin, head of neuroscience at Johnson & Johnson, highlighted the challenges that patients face when dealing with difficult-to-treat depression, stating that these individuals often endure prolonged periods while trying various treatments that fail to alleviate their symptoms, leading to significant emotional and functional distress for both patients and their families.

The application to the FDA is backed by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, can help relieve symptoms within 24 hours and maintain effectiveness for at least four weeks.

Administered as a nasal spray, Spravato must be taken under medical supervision in a healthcare facility. Unlike traditional antidepressants that primarily affect neurotransmitters like serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, which is the most prevalent neurotransmitter and crucial for neuronal communication.

Sales of Spravato experienced a remarkable 60% increase, reaching $271 million in the second quarter, compared to the same period last year. According to Johnson & Johnson, the drug has been utilized by 100,000 patients across 77 countries.

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