Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to extend the approved use of its ketamine-based drug, Spravato, for standalone treatment of treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose conditions did not improve after trying two or more antidepressants. The company 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, commented on the challenges faced by patients, 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 standalone use was accompanied by results from a late-stage clinical trial, which indicated that Spravato could alleviate patients’ symptoms as quickly as 24 hours after treatment and sustain effects for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the observation of a healthcare provider in a clinical environment. Unlike traditional antidepressants that target serotonin and dopamine levels, Spravato enhances glutamate activity in the brain, which is the most prevalent neurotransmitter that facilitates communication between neurons.
Sales for 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, Spravato has been utilized by 100,000 patients across 77 countries.