Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approval of its ketamine-based medication, Spravato, for use as a standalone treatment for resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients whose conditions did not improve after trying two or more antidepressants.
The company reported that nearly 30 percent of the estimated 280 million individuals globally suffering from major depressive disorder experience treatment-resistant depression. Bill Martin, head of neuroscience at Johnson & Johnson, stated that many patients endure lengthy periods trying various treatments that often fail to alleviate their symptoms, imposing a considerable emotional and functional burden on both patients and their families.
The application was supported by data from a late-stage clinical trial, which demonstrated that Spravato, used as a standalone therapy, could alleviate patients’ symptoms as swiftly as 24 hours after administration and maintain this effect for at least four weeks.
Spravato is delivered as a nasal spray and is required to be taken under the supervision of a healthcare provider in a clinical environment. Unlike traditional antidepressants that target brain chemicals like serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate is the brain’s most prevalent neurotransmitter, playing a key role in neuron communication.
Sales of Spravato rose by 60%, reaching $271 million for the quarter ending June 30, compared to the same time frame in 2023. Johnson & Johnson reported that the drug has been utilized by 100,000 patients across 77 countries.