Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the approved use of its ketamine-based medication, Spravato, to function as a standalone therapy for individuals suffering from treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was intended to be used in conjunction with an oral antidepressant for patients whose symptoms did not respond to at least two different antidepressant treatments.
Johnson & Johnson highlighted 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, stated that many patients enduring difficult-to-treat depression often spend excessive time trying multiple ineffective treatments, which can create significant emotional and functional challenges for both patients and their families.
The application for expanded use was supported by data from a late-stage clinical trial, which indicated that Spravato as a standalone treatment began alleviating symptoms as soon as 24 hours after administration and maintained that improvement for a minimum of four weeks.
Administered as a nasal spray, Spravato must be taken under the oversight of a healthcare provider in a clinical setting. In contrast to traditional antidepressants which primarily influence serotonin and dopamine levels in the brain, Spravato enhances glutamate, the most prevalent neurotransmitter, facilitating better communication between neurons.
For the three months ending June 30, Spravato sales surged by 60%, amounting to $271 million, compared to the same period in 2023. According to Johnson & Johnson, Spravato has been utilized by 100,000 patients across 77 countries.