Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based drug, Spravato, as a standalone treatment for individuals suffering from treatment-resistant depression. This application aims to provide a new option for the nearly 30% of the approximately 280 million people worldwide who experience major depressive disorder and do not respond to traditional therapies.
Originally approved by the FDA in 2019, Spravato was intended for use in conjunction with oral antidepressants for patients whose symptoms persisted despite trying two or more different antidepressant medications. Bill Martin, head of neuroscience at Johnson & Johnson, emphasized that many individuals with difficult-to-treat depression often endure a long process of trying various ineffective treatments, resulting in significant emotional and functional challenges for both patients and their families.
The new application is supported by data from a late-stage clinical trial indicating that Spravato can alleviate symptoms as quickly as 24 hours after administration and sustain improvements for at least four weeks. The treatment is delivered as a nasal spray and must be administered under the supervision of a healthcare provider. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato functions by increasing levels of glutamate, the brain’s most prevalent neurotransmitter, facilitating better communication between neurons.
Sales for Spravato have experienced remarkable growth, rising by 60% to $271 million in the second quarter of 2023 compared to the same period last year. To date, approximately 100,000 individuals across 77 countries have utilized Spravato, showcasing its expanding global presence.
This potential expansion of Spravato’s approval marks a hopeful step in the fight against treatment-resistant depression, offering patients a promising alternative when other treatments fail. With ongoing advancements in mental health treatment options, there is optimism for a better quality of life for those who have long struggled with this challenging disorder.