Johnson & Johnson announced on Monday that it has applied to the U.S. Food and Drug Administration (FDA) to extend the approved use of its ketamine-based medication, Spravato, for use as a standalone treatment for treatment-resistant depression.
The FDA initially approved Spravato in 2019 for use alongside an oral antidepressant in patients whose symptoms did not improve after trying two or more antidepressants. Johnson & Johnson noted that nearly 30 percent of the approximately 280 million individuals globally who suffer from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, highlighted the hardship faced by patients with difficult-to-treat depression, stating that they often spend excessive time trying multiple treatments that fail to alleviate their symptoms, leading to significant emotional and functional challenges for both patients and their families.
The submission includes data from a late-stage clinical trial indicating that Spravato, when used alone, began to alleviate symptoms as early as 24 hours after treatment and continued to provide relief for at least four weeks.
Spravato is administered via nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that adjust chemicals like serotonin and dopamine in the brain, Spravato enhances levels of glutamate, the brain’s most abundant neurotransmitter, facilitating communication between neurons.
Sales for Spravato surged by 60% to reach $271 million in the quarter ending June 30, compared to the same period in 2022. The drug has been utilized by 100,000 individuals across 77 countries, as stated by Johnson & Johnson.