Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the usage of its ketamine-based medication, Spravato, allowing it to be used as a standalone treatment for individuals with treatment-resistant depression.
The FDA initially approved Spravato in 2019, permitting its use alongside an oral antidepressant for patients whose symptoms failed to improve after trying two or more other antidepressants. Johnson & Johnson noted that nearly 30 percent of the estimated 280 million people globally who suffer from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release, “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 to the FDA was supported by data from a late-stage clinical trial that demonstrated Spravato’s effectiveness as a standalone therapy, with patients experiencing symptom relief as quickly as 24 hours after treatment, and lasting for at least four weeks.
Administered as a nasal spray, Spravato requires supervision by a healthcare provider in a clinical environment. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter and facilitates communication between neurons.
Sales of Spravato increased by 60% to $271 million in the three months ending June 30, compared to the same quarter in 2023. The medication has been utilized by over 100,000 patients across 77 countries, according to Johnson & Johnson.