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, allowing it to be used independently as a treatment for resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more other antidepressants. Approximately 30 percent of the estimated 280 million individuals experiencing major depressive disorder globally deal with treatment-resistant depression, according to the company.
Bill Martin, head of neuroscience at Johnson & Johnson, stated, “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.”
The submission includes data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, can alleviate symptoms as quickly as 24 hours post-treatment, with effects lasting for at least four weeks afterward.
Spravato is delivered via nasal spray and must be administered under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that primarily influence neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain, the most prevalent neurotransmitter, facilitating neuron communication.
Sales for Spravato surged 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2022. The medication has been used by approximately 100,000 patients across 77 countries, as reported by Johnson & Johnson.