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, as a standalone therapy for treatment-resistant depression.
The FDA initially approved Spravato in 2019 for use alongside an oral antidepressant in patients who did not experience improvement from two or more antidepressants. According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide suffering from major depressive disorder also face treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the struggles of patients with difficult-to-treat depression. “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,” he stated in a press release.
The application to the FDA is supported by data from a late-stage clinical trial indicating that Spravato as a standalone treatment alleviated patients’ symptoms as quickly as 24 hours after administration and continued to do so for at least four weeks.
Spravato is given as a nasal spray and must be administered under the supervision of a healthcare professional in a clinical setting. Unlike other antidepressants that target chemicals like serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, facilitating 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, with the drug having been used by 100,000 patients across 77 countries, according to Johnson & Johnson.