Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based medication, Spravato, allowing it to be used 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 whose symptoms had not improved after trying two or more other antidepressants. According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide suffering from major depressive disorder face treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the struggles many patients endure while navigating multiple ineffective treatment options, which can significantly impact their emotional and functional wellbeing.
The application to the FDA is supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, alleviated symptoms in patients within 24 hours, with effects lasting for at least four weeks.
Spravato is administered via a nasal spray and must be used under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain—a critical neurotransmitter that facilitates neuron communication.
Sales of Spravato increased by 60% to $271 million in the quarter ending June 30, 2023, compared to the same timeframe in the previous year. The medication has been utilized by approximately 100,000 individuals across 77 countries, as reported by Johnson & Johnson.