Johnson & Johnson announced on Monday that it has submitted a proposal to the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based drug, Spravato, as a standalone treatment for individuals with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was allowed to be used in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants. Johnson & Johnson reports that approximately 30% of the 280 million people worldwide living with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the struggles many patients face while navigating through multiple ineffective treatments, which can greatly impact both their functional capabilities and emotional well-being.
The application to the FDA was backed by findings from a late-stage clinical trial, revealing that Spravato as a standalone therapy was effective in alleviating symptoms within just 24 hours and maintained its benefits for at least four weeks after treatment. Importantly, Spravato is delivered via nasal spray and must be administered under the supervision of a healthcare professional.
Unlike traditional antidepressants that primarily affect serotonin and dopamine levels, Spravato uniquely enhances glutamate activity in the brain. Glutamate serves as the brain’s most prevalent neurotransmitter and plays a crucial role in neuronal communication.
Sales for Spravato have seen a notable increase, rising by 60% to reach $271 million in the second quarter of 2023 compared to the same period last year. The drug has been utilized by approximately 100,000 individuals across 77 countries, showcasing its growing acceptance and reach in the mental health landscape.
This development offers hope for countless individuals struggling with depression, particularly those who have not found relief through traditional methods. With advancements in treatment options like Spravato, there is a brighter outlook for patients who face the challenges of treatment-resistant conditions.