Johnson & Johnson announced on Monday that it has submitted a new application to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based drug, Spravato, as a standalone treatment for individuals suffering from treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designed to be used alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more other antidepressants. Johnson & Johnson highlighted that nearly 30 percent of the estimated 280 million people globally living with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated that “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,” emphasizing the importance of this application.
The new submission is supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, alleviated symptoms in patients as soon as 24 hours after administration, with effects lasting for at least four weeks.
Spravato is delivered as a nasal spray and is required to be administered under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that focus on regulating neurotransmitters such as serotonin and dopamine, Spravato enhances the activity of glutamate in the brain, which is the most prevalent neurotransmitter and is essential for neuronal communication.
Sales for Spravato experienced a significant increase of 60%, reaching $271 million in the quarter ending June 30, compared to the same period in the previous year. The drug has been utilized by over 100,000 people across 77 countries, according to the company.