Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-derived medication, Spravato, to function as a standalone treatment for treatment-resistant depression.
Spravato received FDA approval in 2019, initially intended for use alongside an oral antidepressant for patients whose conditions did not improve despite trying two or more antidepressants.
Johnson & Johnson highlighted that nearly 30 percent of the 280 million individuals globally affected by major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, expressed concern in a press release, stating, “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 application is supported by data from a late-stage clinical trial that indicated Spravato, when used as a standalone therapy, alleviated patients’ symptoms as quickly as 24 hours after treatment and maintained effectiveness for at least four weeks.
Spravato is administered as a nasal spray and must be used under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that affect chemicals like serotonin and dopamine, Spravato acts by enhancing glutamate levels in the brain, facilitating communication between neurons.
Sales for Spravato increased by 60%, reaching $271 million in the quarter ending June 30 compared to the same period in 2022. The medication has been utilized by around 100,000 individuals across 77 countries, according to Johnson & Johnson.