Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based medication, Spravato, as a standalone treatment for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients who did not see improvement after trying two or more antidepressants.
According to Johnson & Johnson, approximately 30 percent of the estimated 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, highlighted the challenges faced by patients with difficult-to-treat depression, stating that many endure a lengthy process of trying various treatments without success, which inflicts a significant emotional and functional burden on both themselves and their families.
The application to the FDA includes data from a late-stage clinical trial indicating that Spravato, when used alone, can alleviate symptoms within 24 hours and provide relief for at least four weeks.
Spravato is administered as a nasal spray and must be administered under the supervision of a healthcare provider. Unlike traditional antidepressants that target serotonin and dopamine, Spravato enhances glutamate levels in the brain, the most abundant neurotransmitter that facilitates communication between neurons.
Sales figures reveal that Spravato’s revenue surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2022. Johnson & Johnson reports that the medication has been prescribed to 100,000 patients across 77 countries.