Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the approved usage of its ketamine-based medication, Spravato, for treating resistant depression as a standalone therapy.
Approved by the FDA in 2019, Spravato was initially authorized to be used alongside an oral antidepressant for patients who did not see improvements after trying two or more antidepressants. Johnson & Johnson highlighted that approximately 30% of the 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients with hard-to-treat depression, stating that many struggle for extended periods with multiple treatments that ultimately fail to alleviate their symptoms, leading to significant emotional and functional distress for both patients and their families.
The application for standalone usage is supported by data from a late-stage clinical trial which indicated that Spravato could begin to alleviate patients’ symptoms as soon as 24 hours after treatment and maintain its effectiveness for at least four weeks.
Administered as a nasal spray, Spravato requires supervision during its application in a healthcare environment. Its unique mechanism of action distinguishes it from other antidepressants, as it enhances glutamate levels in the brain instead of regulating serotonin and dopamine.
Sales for Spravato surged 60%, reaching $271 million for the three months ending June 30, compared to the same period in 2023. The medication has been utilized by around 100,000 individuals across 77 countries, according to Johnson & Johnson.
This potential expansion of Spravato’s usage could offer hope to many patients struggling with depression who have found no relief from traditional treatments. As ongoing research and development in the field of mental health continue to evolve, it may lead to new, more effective solutions for those in need of support.