Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) seeking to expand the usage of its ketamine-based medication, Spravato, as a standalone treatment for patients suffering from treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was indicated for use alongside an oral antidepressant in patients whose symptoms failed to improve with multiple other antidepressants.
The company highlighted that nearly 30 percent of the estimated 280 million individuals worldwide who have major depressive disorder are affected by treatment-resistant depression. Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the prolonged struggle many patients face when they have to try various treatments that often do not alleviate their symptoms, leading to significant emotional and functional challenges for both patients and their families.
The application for expanded use is backed by data from a late-stage clinical trial, which demonstrated that Spravato as a standalone treatment could alleviate symptoms as soon as 24 hours post-treatment and maintain effectiveness for a minimum of four weeks.
Spravato is administered via a nasal spray and is required to be taken under the supervision of a healthcare professional in a medical environment. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, which is the most prevalent neurotransmitter and essential for neuronal communication.
Sales figures show that Spravato’s revenue increased by 60% to $271 million in the three months ending June 30, compared to the same period in the previous year. To date, Johnson & Johnson reports that Spravato has been utilized by 100,000 patients across 77 countries.