Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based drug, Spravato, allowing it to be prescribed as a standalone treatment for individuals with treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was designed to be used in conjunction with an oral antidepressant for patients who did not see improvements after trying two or more other antidepressant medications. According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people worldwide suffering from 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 application to the FDA was supported by results from a late-stage clinical trial indicating that Spravato, when used alone, alleviated patients’ symptoms as soon as 24 hours post-treatment and continued to do so for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a medical environment. Unlike traditional antidepressants that typically target neurotransmitters such as serotonin and dopamine, Spravato acts by enhancing glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter and plays a key role in neuronal communication.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same time frame in 2023, with Johnson & Johnson reporting that the drug has been utilized by 100,000 individuals across 77 countries.