Johnson & Johnson announced on Monday that it has formally requested approval from the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based medication, Spravato, so that it can be administered as a standalone treatment for patients suffering from treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designed to be used in conjunction with an oral antidepressant for individuals whose depression did not improve after trying two or more other antidepressants.
Johnson & Johnson noted that nearly 30 percent of the 280 million people globally diagnosed with major depressive disorder experience treatment-resistant depression. Bill Martin, head of neuroscience at Johnson & Johnson, expressed the challenges these patients face, stating that many endure prolonged periods of trialing various treatments that fail to alleviate their symptoms, leading to significant emotional and functional distress for both them and their families.
The submission for expanded use is backed by findings from a late-stage clinical trial indicating that Spravato, when used alone, can begin to alleviate symptoms within 24 hours and maintain efficacy for at least four weeks.
Spravato is delivered as a nasal spray and must be administered in a healthcare setting under professional supervision. Unlike traditional antidepressants that target brain chemicals such as serotonin and dopamine, Spravato enhances levels of glutamate, a neurotransmitter crucial for neuronal communication.
Sales of Spravato increased by 60% to $271 million in the second quarter of 2023 compared to the same period last year. According to Johnson & Johnson, the drug has been utilized by approximately 100,000 patients across 77 countries.