Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) seeking to expand the approved use of its ketamine-based medication, Spravato, to serve as a standalone treatment for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside oral antidepressants for patients whose symptoms did not improve with two or more different antidepressant medications. Johnson & Johnson noted that nearly 30% of the estimated 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release that many patients struggling with difficult-to-treat depression often go through numerous treatments without finding relief, resulting in considerable emotional and functional challenges for them and their families.
The application to the FDA includes data from a late-stage clinical trial, which demonstrated that Spravato, when used alone, significantly alleviated symptoms within 24 hours of treatment and provided relief for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the oversight of a healthcare provider in a clinical setting. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter and plays a crucial role in neuronal communication.
Additionally, sales of Spravato surged by 60% to reach $271 million during the three months ending June 30, compared to the same period in the previous year. The drug has been utilized by approximately 100,000 individuals across 77 countries, according to Johnson & Johnson.