Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based drug, Spravato, as a standalone treatment for individuals with treatment-resistant depression.
Spravato was first approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms were unresponsive to two or more antidepressant therapies. The company noted that approximately 30% of the 280 million people globally affected by major depressive disorder experience treatment-resistant forms of the condition.
Bill Martin, head of neuroscience at Johnson & Johnson, highlighted the significant challenges faced by patients with hard-to-treat depression, stating, “Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones.”
The latest application includes results from a late-stage clinical trial demonstrating that Spravato, used as a standalone therapy, provided relief from symptoms within 24 hours of treatment and maintained efficacy for at least four weeks.
Spravato is administered as a nasal spray and requires administration under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that focus on regulating brain chemicals like serotonin and dopamine, Spravato targets glutamate, the brain’s most abundant neurotransmitter, to enhance neuronal communication.
Sales of Spravato have surged by 60%, reaching $271 million in the three months ending June 30, compared to the same period in 2023. Johnson & Johnson reported that the drug has been utilized by 100,000 patients across 77 countries.