Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to extend the approved use of its ketamine-based medication, Spravato, for use as a standalone therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019, but only for use alongside an oral antidepressant in patients whose symptoms did not improve after trying two or more antidepressants. According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals globally who suffer from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients enduring difficult-to-treat depression, noting that many spend excessive time trying multiple treatments that fail to alleviate their symptoms, resulting in both functional and emotional strain on them and their families.
The application submitted to the FDA includes data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, can begin alleviating symptoms as quickly as 24 hours after administration and can maintain these effects for at least four weeks.
Spravato is delivered via a nasal spray and must be administered under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that affect neurotransmitters like serotonin and dopamine, Spravato increases levels of glutamate, the brain’s most prevalent neurotransmitter, facilitating communication between neurons.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in 2023, and the medication has been utilized by 100,000 patients across 77 countries, according to Johnson & Johnson.