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 drug, Spravato, so that it can be prescribed as a standalone treatment for patients suffering from treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for individuals whose symptoms did not improve after trying two or more antidepressants. According to Johnson & Johnson, approximately 30 percent of the 280 million people globally affected by major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, stated in a press release, “Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones.”
The submission was based on data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, began to alleviate patients’ symptoms as soon as 24 hours after administration and maintained this effect for at least four weeks.
Spravato is delivered as a nasal spray and requires administration under the supervision of a healthcare provider in a medical setting. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, improving communication between neurons.
Sales of Spravato surged by 60% to $271 million in the three months ending June 30, compared to the same timeframe in 2022. The medication has been utilized by 100,000 individuals across 77 countries, according to the company.