Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to extend the use of its ketamine-based medication, Spravato, so that it can be utilized as a standalone treatment for those suffering from treatment-resistant depression.
Spravato was initially approved by the FDA in 2019, but only for use in conjunction with an oral antidepressant for patients whose symptoms persist despite trying two or more antidepressant medications.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people worldwide affected by major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release the struggles faced by patients dealing with difficult-to-treat depression, stating that many often endure extended periods while trying various treatments that do not alleviate their symptoms, leading to significant emotional and functional strain on them and their families.
This application comes with data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, can significantly improve patients’ symptoms as quickly as 24 hours after administration and sustain these improvements for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a medical environment. Unlike conventional antidepressants that affect neurotransmitters like serotonin and dopamine, Spravato enhances the levels of glutamate in the brain. Glutamate is the brain’s most prevalent neurotransmitter and is essential for neuronal communication.
Sales of Spravato surged by 60%, reaching $271 million for the quarter ending June 30, compared to the same quarter in 2023. Johnson & Johnson reports that Spravato has already been utilized by around 100,000 patients across 77 countries.