Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved uses of its ketamine-based medication, Spravato. The company seeks to allow Spravato to be used as a standalone treatment for individuals suffering from treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designed to be used in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more different antidepressants. Johnson & Johnson highlighted that close to 30 percent of the approximately 280 million people diagnosed with major depressive disorder globally experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized the plight of patients dealing with difficult-to-treat depression, noting that they often endure long periods of switching between various treatments without relief. This can create significant emotional and functional burdens for both patients and their families.
The recent application to the FDA includes findings from a late-stage clinical trial indicating that Spravato can alleviate symptoms as quickly as 24 hours after administration, showing benefits that can last for at least four weeks. Administration of Spravato is conducted via a nasal spray and occurs in a healthcare setting under professional supervision. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances the levels of glutamate, the brain’s most prevalent neurotransmitter, which is crucial for neuronal communication.
Sales of Spravato have experienced remarkable growth, soaring by 60% to $271 million in the second quarter compared to the same timeframe in 2023. The medication has been utilized by 100,000 patients across 77 countries, demonstrating its global reach and impact.
This news brings hope to those struggling with treatment-resistant depression, as a more immediate and effective treatment option could soon be available, potentially transforming lives and improving mental health outcomes for countless individuals worldwide.