Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, seeking to allow it to be used as a standalone therapy for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was authorized for use alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals globally diagnosed with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients dealing with difficult-to-treat depression, stating that many spend excessive time trying various treatments that fail to alleviate their symptoms, which can lead to considerable emotional and functional difficulties for both patients and their families.
The application for expanded use was supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, could alleviate symptoms as quickly as 24 hours post-treatment and maintain effectiveness for at least four weeks.
Spravato is administered via a nasal spray and must be taken under the supervision of a healthcare provider in a medical setting. Unlike traditional antidepressants that primarily target brain chemicals like serotonin and dopamine, Spravato functions by increasing glutamate levels in the brain, which is the most prevalent neurotransmitter and facilitates communication between neurons.
Sales of Spravato surged by 60% to $271 million in the three months ending June 30, compared to the same period in the previous year. Johnson & Johnson reports that the medication has been utilized by 100,000 patients across 77 countries.