Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) aimed at expanding the approved use of its ketamine-based medication, Spravato, to function as a standalone therapy for treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was designated for use in conjunction with an oral antidepressant for patients whose depression symptoms remained unresponsive to two or more prior antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people worldwide living with major depressive disorder are affected by treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release the struggle of patients enduring difficult-to-treat depression, who often spend excessive time trying multiple ineffective treatments, leading to significant emotional and functional challenges for themselves and their families.
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The application includes findings from a late-stage clinical trial indicating that Spravato, when used as a standalone therapy, began alleviating symptoms in patients as early as 24 hours after administration, showing effects lasting for at least four weeks.
Spravato is administered as a nasal spray and requires supervision by a healthcare provider in a medical setting. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, a key neurotransmitter essential for neuronal communication.
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Sales of Spravato experienced a substantial increase of 60%, reaching $271 million for the quarter ending June 30, compared to the same timeframe in the previous year. To date, 100,000 individuals across 77 countries have utilized Spravato, according to Johnson & Johnson.