Johnson & Johnson announced on Monday that it has filed a request with the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based drug, Spravato, allowing it to be utilized as a standalone treatment for patients suffering from treatment-resistant depression.
Spravato received its initial FDA approval in 2019 for use in conjunction with an oral antidepressant for individuals whose conditions did not improve after trying two or more antidepressants. Approximately 30 percent of the 280 million people worldwide diagnosed with major depressive disorder experience treatment-resistant depression, according to Johnson & Johnson.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the struggles faced by patients with difficult-to-treat depression, stating that they often spend extensive time trying various treatments that fail to alleviate their symptoms, which can be a significant emotional and functional burden for both them and their families.
The application for expanded use is backed by data from a late-stage clinical trial indicating that Spravato, when used alone, may begin to relieve symptoms within just 24 hours of treatment and continue to provide relief for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a clinical environment. Unlike traditional antidepressants that affect neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter and plays a crucial role in neuronal communication.
Sales of Spravato surged by 60%, reaching $271 million in the second quarter of 2023 compared to the same period in the previous year. The drug has been utilized by approximately 100,000 patients across 77 countries, according to the company.