Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) seeking to broaden the approved use of its ketamine-based medication, Spravato, to function as a standalone therapy for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was authorized for use in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more other antidepressants.
Johnson & Johnson noted that nearly 30 percent of the approximately 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated, “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 application for expanded use was backed by data from a late-stage clinical trial indicating that Spravato as a standalone treatment could begin alleviating patients’ symptoms within 24 hours and continue to do so for at least four weeks.
Spravato is administered as a nasal spray and is required to be used under the supervision of a healthcare professional in a clinical setting. Unlike conventional antidepressants that target serotonin and dopamine levels, Spravato enhances glutamate in the brain, which is the most prevalent neurotransmitter, aiding neuron communication.
Sales of Spravato saw a remarkable 60% increase, totaling $271 million in the quarter ending June 30, compared to the same period in 2023. According to Johnson & Johnson, Spravato has been utilized by 100,000 patients across 77 countries.