Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based drug, Spravato, to function as a standalone treatment for those 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 depression did not respond to two or more antidepressant medications. Notably, nearly 30% of the approximately 280 million individuals worldwide who are diagnosed with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, highlighted the urgency of the matter, stating, “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 FDA application is backed by data from a late-stage clinical trial that demonstrated Spravato’s effectiveness as a standalone therapy, showing symptom relief as early as 24 hours post-treatment and lasting for at least four weeks. Administered through a nasal spray, Spravato must be taken under healthcare supervision. Unlike traditional antidepressants that modify serotonin and dopamine levels, Spravato enhances glutamate activity in the brain, which is crucial for neuronal communication.
In terms of sales, Spravato has experienced a remarkable 60% increase, bringing in $271 million in revenue for the quarter ending June 30, 2023. The drug has been utilized by over 100,000 patients across 77 countries, reflecting its growing acceptance and potential in the treatment landscape.
This development could greatly improve the lives of those living with challenging depressive disorders, offering hope where other treatments have failed. The continued innovation and research by Johnson & Johnson signal a positive trend in the ongoing fight against mental health issues, illuminating the path for better treatment options for those who desperately need them.