Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-derived medication, Spravato, allowing it to be utilized as a standalone therapy for treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was intended to be used alongside oral antidepressants for patients whose depression symptoms did not improve after trying two or more different antidepressants.
The company highlighted that nearly 30 percent of the estimated 280 million individuals worldwide suffering from 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 includes findings from a recent late-stage clinical trial demonstrating that Spravato, when used as a standalone treatment, alleviated symptoms in patients within 24 hours and maintained these effects for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the observation of a healthcare professional in a clinical setting. Unlike other antidepressants that target neurotransmitters like serotonin and dopamine, Spravato increases levels of glutamate, the brain’s most prevalent neurotransmitter, facilitating communication between neurons.
In terms of financial performance, sales of Spravato surged by 60% to reach $271 million in the quarter ending June 30, compared to the same period last year. The medication has been used by approximately 100,000 individuals across 77 countries, as reported by Johnson & Johnson.