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 medication, Spravato, allowing it to be utilized as a standalone treatment for individuals with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designed to be used in conjunction with an oral antidepressant for patients who did not experience improvement after trying two or more antidepressants. According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people worldwide living with major depressive disorder suffer from 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 includes results from a late-stage clinical trial demonstrating that Spravato, when used alone, can alleviate symptoms as soon as 24 hours post-treatment and continue to provide relief for at least four weeks.
Spravato is administered via nasal spray and must be taken under the supervision of a healthcare professional in a medical setting. Unlike traditional antidepressants that target the regulation of serotonin and dopamine, Spravato operates by enhancing glutamate levels in the brain, which is the most prevalent neurotransmitter and plays a vital role in neuronal communication.
Sales of Spravato have surged by 60%, reaching $271 million in the quarter ending June 30, when compared to the same quarter in 2023. The medication has been utilized by approximately 100,000 individuals across 77 countries, according to Johnson & Johnson.