Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone treatment for patients with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019, but only in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants. Johnson & Johnson noted that nearly 30 percent of the approximately 280 million individuals worldwide who suffer from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the urgent need for better treatment options, 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 application for expanded use was supported by results from a late-stage clinical trial, which indicated that Spravato, when used as a standalone treatment, demonstrated the ability to alleviate symptoms within 24 hours and provided relief for at least four weeks.
Spravato is administered via a nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that target serotonin and dopamine levels, Spravato functions by enhancing glutamate activity in the brain. Glutamate, the most prevalent neurotransmitter, facilitates communication between neurons.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in the previous year. According to Johnson & Johnson, the medication has been employed by 100,000 individuals across 77 countries.