Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approval of its ketamine-based medication, Spravato, allowing it to be used as a standalone treatment for resistant depression.
The FDA first granted approval to Spravato in 2019, specifying that it should be used alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants.
Johnson & Johnson highlighted that nearly 30 percent of the approximately 280 million people 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 submitted to the FDA includes data from a late-stage clinical trial indicating that Spravato, when used independently, began alleviating 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 guidance of a healthcare professional in a clinical setting. Unlike conventional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances glutamate activity in the brain. Glutamate is the most prevalent neurotransmitter and is key for neuronal communication.
Sales of Spravato surged by 60%, reaching $271 million in the second quarter of 2023 compared to the same quarter the previous year. To date, Spravato has been utilized by 100,000 patients across 77 countries, as reported by Johnson & Johnson.