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, for treating resistant depression as a standalone therapy.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant in patients whose symptoms did not improve after trying two or more different antidepressants.
According to Johnson & Johnson, nearly 30% of the estimated 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized that “many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones,” in a press release.
The application to the FDA includes data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone treatment, relieved patients’ symptoms as quickly as 24 hours after administration and sustained relief for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain, a key neurotransmitter that aids in neuronal communication.
Sales of Spravato surged 60%, reaching $271 million during the three months ending June 30, compared to the same period in 2022. The drug has been utilized by 100,000 individuals across 77 countries, according to Johnson & Johnson.