Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) seeking approval to use its ketamine-based medication, Spravato, as a standalone treatment for individuals suffering from treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designed to be used alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people worldwide living with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the struggles faced by patients enduring difficult-to-treat depression, stating that many spend excessive time trying various treatments that fail to alleviate their symptoms, leading to significant emotional and functional challenges for both patients and their families.
The application for Spravato’s standalone use was backed by data from a late-stage clinical trial, indicating that it provided symptom relief to patients as soon as 24 hours after administration and maintained effectiveness 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 serotonin and dopamine levels, Spravato enhances glutamate levels in the brain, a crucial neurotransmitter that facilitates neuronal communication.
Sales of Spravato surged by 60% to $271 million during the quarter ending June 30, compared to the same period in 2023. The medication has been utilized by approximately 100,000 individuals across 77 countries, according to Johnson & Johnson.