Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the approved use of its ketamine-based drug, Spravato, to function as a standalone treatment for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant in patients who have not responded to two or more prior antidepressant treatments. According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression.
Bill Martin, 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 FDA application is supported by data from a late-stage clinical trial indicating that Spravato, when used alone, alleviated patients’ symptoms as early as 24 hours post-treatment and continued to do so for at least four weeks.
Spravato is administered as a nasal spray and must be taken under medical supervision in a healthcare setting. Unlike traditional antidepressants that affect neurotransmitters such as serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, which is the most predominant neurotransmitter and plays a crucial role in neural communication.
In financial results, sales of Spravato saw a significant jump, increasing by 60% to $271 million in the three months ending June 30, compared to the same period in 2023. According to Johnson & Johnson, the drug has been utilized by 100,000 patients across 77 countries.