Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the approved usage of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone treatment for individuals with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designated for use alongside an oral antidepressant for patients who did not see improvements after trying at least two different antidepressants. Johnson & Johnson noted that nearly 30% of the approximately 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression, underscoring the urgent need for effective therapies.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized that many individuals struggle for too long with multiple treatments that fail to alleviate their symptoms, imposing a significant emotional and functional strain on them and their families.
The application for expanded use includes findings from a late-stage clinical trial, which indicated that Spravato, when administered alone, could help alleviate symptoms as quickly as 24 hours post-treatment and maintain its effectiveness for at least four weeks. Spravato is delivered as a nasal spray and must be used under medical supervision.
Distinct from traditional antidepressants that target serotonin and dopamine levels, Spravato enhances glutamate levels, the most abundant neurotransmitter in the brain, which facilitates neuronal communication.
The sales of Spravato have seen a notable increase, rising 60% to $271 million for the quarter ending June 30 compared to the same period in the previous year. Furthermore, it has been utilized by 100,000 patients across 77 countries, reflecting its growing acceptance and demand.
This development brings hope to countless individuals grappling with depression, as it highlights the potential for new therapeutic options that could drastically improve their quality of life. The ongoing commitment to research and innovation in mental health treatment represents progress in the field and a brighter future for those seeking relief from debilitating conditions.