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 therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in combination with an oral antidepressant for patients who did not respond to two or more antidepressants. The company stated 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, emphasized the significance of this application, noting that many patients endure prolonged struggles with multiple treatments that fail to alleviate their symptoms, leading to considerable emotional and functional difficulties for both patients and their families.
The application includes data from a late-stage clinical trial that demonstrated Spravato’s effectiveness as a standalone treatment, with patients showing symptom relief as soon as 24 hours after administration and sustaining improvements for at least four weeks.
Spravato is delivered via nasal spray and must be administered under the supervision of a healthcare provider in a medical setting. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances the activity of glutamate, the most prevalent neurotransmitter in the brain, facilitating communication between neurons.
Sales of Spravato surged by 60% to reach $271 million in the three months ending June 30, compared to the same period in 2022. The drug has been utilized by around 100,000 patients across 77 countries, according to Johnson & Johnson.