Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, allowing it to be administered as a standalone treatment for individuals suffering from treatment-resistant depression.
Spravato initially received FDA approval in 2019 for use in conjunction with an oral antidepressant for patients who did not see improvements after two or more traditional antidepressant therapies. Currently, around 30% of the estimated 280 million people worldwide with major depressive disorder struggle with treatment-resistant depression, as noted by Johnson & Johnson.
Bill Martin, the head of neuroscience at Johnson & Johnson, highlighted the urgent need for effective treatments, 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 application to the FDA includes positive results from a recent late-stage clinical trial, demonstrating that Spravato as a standalone therapy proved effective in alleviating symptoms within just 24 hours for many patients and sustained relief for at least four weeks.
Spravato is provided as a nasal spray and must be administered under medical supervision. Unlike traditional antidepressants that focus on neurotransmitters like serotonin and dopamine, Spravato enhances levels of glutamate, a crucial neurotransmitter in brain communication.
Sales for Spravato have surged by 60%, reaching $271 million in the second quarter of 2023 compared to the same timeframe last year. The drug has already benefited approximately 100,000 individuals across 77 countries.
In summary, the expansion application for Spravato signifies Johnson & Johnson’s commitment to providing new solutions for those battling treatment-resistant depression. This move holds promise for millions seeking effective therapies, reinforcing the importance of innovative approaches in mental health treatment. The rising sales of Spravato reflect a growing recognition of its impact and relevance in addressing mental health challenges globally.