Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the approved use of its ketamine-derived medication Spravato, aiming to designate it as a standalone treatment for individuals suffering from treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people globally diagnosed with major depressive disorder experience treatment-resistant depression.
“Many patients dealing with difficult-to-treat depression endure prolonged periods cycling through various treatments that fail to effectively alleviate their symptoms, placing a substantial functional and emotional burden on them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application was supported by data from a late-stage clinical trial showing that Spravato, when used alone, alleviated patients’ symptoms as early as 24 hours post-treatment and was effective 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 typical antidepressants that modulate brain chemicals like serotonin and dopamine, Spravato enhances levels of glutamate, the brain’s most prevalent neurotransmitter, which plays a critical role in neuronal communication.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson reported that Spravato has been prescribed to 100,000 patients across 77 countries.