Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-derived drug, Spravato, for treatment-resistant depression as a standalone therapy.
Initially approved by the FDA in 2019, Spravato was designated for use alongside an oral antidepressant for patients who did not experience relief from two or more traditional antidepressants. Johnson & Johnson highlighted that nearly 30% of the approximately 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the significant emotional and functional strain this condition places on patients and their families, noting that individuals often endure lengthy trials of ineffective therapies.
The application for expanded use is supported by data from a late-stage clinical trial, which indicated that Spravato could alleviate symptoms within as little as 24 hours and maintain its efficacy for at least four weeks. Administered as a nasal spray, Spravato is given under medical supervision in a healthcare facility. Unlike conventional antidepressants that influence serotonin and dopamine levels, Spravato operates by enhancing glutamate, the brain’s most prevalent neurotransmitter, thus facilitating neuronal communication.
Sales of Spravato experienced a notable surge of 60%, rising to $271 million in the three months ending June 30, compared to the same timeframe in 2023. To date, the drug has been utilized by 100,000 individuals across 77 different countries.
This advancement in treatment options is a beacon of hope for those grappling with treatment-resistant depression, potentially offering a solution that may significantly improve their quality of life. As ongoing research and development in mental health treatments continue to evolve, there is optimism for more effective therapies to emerge in the near future.