Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, allowing it to be used as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant in patients whose symptoms did not improve after trying two or more antidepressant medications.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people globally who suffer from major depressive disorder experience treatment-resistant depression. Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients, stating that many struggle for extended periods trying numerous treatments that fail to alleviate their symptoms, leading to significant emotional and functional stress for them and their families.
The application to the FDA was supported by data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone therapy, significantly reduced patients’ symptoms as quickly as 24 hours post-treatment and maintained those improvements for at least four weeks.
Spravato is delivered as a nasal spray and must be administered in a healthcare setting under the supervision of a healthcare professional. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato functions by increasing glutamate levels in the brain, enhancing neuronal communication.
Sales of Spravato surged by 60% to $271 million for the three months ending June 30, compared to the same period in 2023. Johnson & Johnson reported that the medication has been utilized by approximately 100,000 patients across 77 countries.