Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based medication, Spravato, as a standalone therapy for those suffering from treatment-resistant depression. Initially approved in 2019, Spravato was designed to be used alongside an oral antidepressant for patients who did not see improvements after trying two or more different antidepressants.
The company highlighted that nearly 30 percent of the 280 million individuals globally living with major depressive disorder struggle with treatment-resistant depression. Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients dealing with hard-to-treat depression, pointing out that many endure long periods of ineffective treatment, which can significantly affect their emotional well-being and daily life.
The application to the FDA was supported by findings from a late-stage clinical trial, which indicated that Spravato as a solo treatment improved patient symptoms as quickly as 24 hours after administration and continued to do so for at least four weeks. Spravato is administered via a nasal spray and must be taken under medical supervision. Distinct from other antidepressants that typically alter serotonin and dopamine levels, Spravato utilizes a different mechanism by enhancing glutamate activity, the brain’s most prevalent neurotransmitter, which facilitates communication between neurons.
Sales for Spravato have seen remarkable growth, with a 60% increase to $271 million for the quarter ending June 30 compared to the same period in 2023. The medication is currently in use by approximately 100,000 patients across 77 countries.
This advancement by Johnson & Johnson represents a significant step forward in addressing the mental health crisis, particularly for those who have found little relief through traditional treatments. If approved, this could provide a much-needed lifeline for countless individuals grappling with depression, paving the way for more effective therapeutic options.