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, allowing it to be used as a standalone therapy for treatment-resistant depression.
Initially approved in 2019, Spravato was designed to be used alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressant medications.
Johnson & Johnson highlighted that approximately 30 percent of the estimated 280 million individuals 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 company’s application is backed by data from a late-stage clinical trial demonstrating that Spravato, when administered alone, alleviated patients’ symptoms as quickly as 24 hours after treatment and maintained efficacy for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider. Unlike traditional antidepressants that target brain chemicals like serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, which is the most prevalent neurotransmitter and facilitates communication between neurons.
Sales of Spravato increased by 60%, reaching $271 million in the quarter ending June 30, compared to the same quarter in 2023. The drug has been utilized by 100,000 individuals across 77 countries, according to Johnson & Johnson.