Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, so it can be utilized as a standalone therapy for individuals with treatment-resistant depression.
Spravato, which received its initial approval from the FDA in 2019, was originally designated for use in conjunction with an oral antidepressant for patients whose symptoms did not improve after multiple antidepressant treatments.
Johnson & Johnson noted that nearly 30 percent of the estimated 280 million people globally suffering from major depressive disorder experience treatment-resistant depression. Bill Martin, head of neuroscience at the company, emphasized the difficulties many patients face when trying different treatments that fail to alleviate their symptoms, resulting in significant emotional and functional struggles for both patients and their families.
The application to the FDA included findings from a late-stage clinical trial indicating that Spravato, when used alone, could alleviate patients’ symptoms within 24 hours of administration and maintain these benefits for at least four weeks.
Spravato is delivered as a nasal spray and is required to be administered under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that focus on regulating neurotransmitters like serotonin and dopamine, Spravato enhances the action of glutamate, the brain’s most prevalent neurotransmitter, facilitating communication between neurons.
The sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson reported that the drug has been utilized by 100,000 patients across 77 countries.