Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based drug, Spravato, as a standalone treatment for treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was intended to be used alongside an oral antidepressant for patients whose depression did not improve after trying two or more antidepressant medications.
The company stated that nearly 30 percent of the estimated 280 million individuals globally living with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized that many patients face prolonged struggles with various treatments that fail to alleviate their symptoms, creating significant emotional and functional challenges for both patients and their families.
The application for the expanded use was backed by data from a late-stage clinical trial, which revealed that Spravato as a standalone treatment could relieve symptoms within 24 hours and maintain relief for at least four weeks.
Spravato is delivered via a nasal spray and must be administered in a healthcare setting under professional supervision. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances the brain’s glutamate levels, which is the most prevalent neurotransmitter and essential for effective neuron communication.
Sales of Spravato surged by 60% to $271 million in the three-month period ending June 30 compared to the same timeframe in 2023. The medication has been used by approximately 100,000 individuals across 77 countries, according to the company.