Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based drug, Spravato, allowing it to be utilized as a standalone treatment for individuals with treatment-resistant depression.
A recent study indicated that the pill version of Novo Nordisk’s drug Ozempic can reduce the risk of heart attacks and strokes. The FDA initially approved Spravato in 2019 for use alongside an oral antidepressant in patients whose symptoms failed to improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people globally who suffer from major depressive disorder have treatment-resistant depression. Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release that many patients endure lengthy periods trying different treatments that do not alleviate their symptoms, leading to significant emotional and functional strain on both patients and their families.
The application to the FDA includes data from a late-stage clinical trial demonstrating that Spravato, when used alone, can alleviate symptoms of depression as soon as 24 hours after administration and sustain improvements for at least four weeks.
Spravato is delivered as a nasal spray and must be taken under the supervision of a healthcare professional. Unlike conventional antidepressants that typically adjust neurotransmitters like serotonin and dopamine, Spravato functions by enhancing levels of glutamate in the brain, which is the most abundant neurotransmitter and is essential for neuronal communication.
Sales for Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in 2022. The drug has been prescribed to 100,000 patients across 77 countries, according to Johnson & Johnson.