Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based medication, Spravato, for standalone treatment of treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant in patients whose symptoms have not improved after trying two or more other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release, “Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, leading to significant functional and emotional burdens on both patients and their families.”
The submission included data from a late-stage clinical trial, indicating that Spravato, as a standalone treatment, was successful in alleviating patients’ symptoms as soon as 24 hours after administration and sustained relief for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a medical setting. Unlike conventional antidepressants that primarily affect serotonin and dopamine levels in the brain, Spravato enhances glutamate activity. Glutamate, the brain’s most prevalent neurotransmitter, is vital for effective neuronal communication.
Sales for Spravato surged by 60% to $271 million during the quarter ending June 30, compared to the same timeframe in 2023. The medication has been utilized by approximately 100,000 individuals across 77 countries, as reported by Johnson & Johnson.