Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based drug, Spravato, allowing it to be employed as a standalone treatment for individuals suffering from treatment-resistant depression.
The FDA initially approved Spravato in 2019 for use alongside an oral antidepressant in patients who had not shown improvement after trying two or more antidepressants. Johnson & Johnson highlighted that nearly 30 percent of the estimated 280 million individuals worldwide diagnosed 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 application was supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, alleviated patients’ symptoms as quickly as 24 hours after administration and maintained this effect for at least four weeks.
Spravato, delivered via nasal spray, must be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances the levels of glutamate in the brain, which is the most prevalent neurotransmitter and plays a crucial role in neuronal communication.
Sales of Spravato increased by 60% to $271 million for the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson reported that the drug has already been utilized by 100,000 individuals across 77 countries.