Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based drug, Spravato, to be utilized as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 as a therapeutic option when used in conjunction with an oral antidepressant, specifically for patients whose conditions did not improve after trying two or more antidepressants.
The company highlighted that around 30 percent of the approximately 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression. Johnson & Johnson’s head of neuroscience, Bill Martin, emphasized the struggles faced by these patients, stating that many endure prolonged periods trying various ineffective treatments, which can significantly impact both their quality of life and that of their families.
The recent application to the FDA includes findings from a late-stage clinical trial demonstrating that Spravato, when used alone, can alleviate symptoms within as little as 24 hours and maintain effectiveness for at least four weeks post-treatment.
Spravato, delivered via a nasal spray, is required to be taken under the supervision of a healthcare professional in a clinical environment. Unlike traditional antidepressants that typically target neurotransmitters like serotonin and dopamine, Spravato operates by increasing glutamate levels in the brain, which is the most prevalent neurotransmitter and vital for neuronal communication.
Sales for Spravato experienced a significant increase of 60%, totaling $271 million in the three months ending June 30, compared to the same timeframe in 2023. To date, approximately 100,000 individuals in 77 countries have used Spravato, according to Johnson & Johnson.