Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based drug, Spravato, as a standalone treatment for individuals with treatment-resistant depression.
Spravato, which received FDA approval in 2019, was initially authorized for use in conjunction with an oral antidepressant for patients whose depression did not improve after trying two or more antidepressants.
The company noted that nearly 30 percent of the approximately 280 million people globally who suffer from major depressive disorder experience treatment-resistant depression. Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the challenges faced by these patients, 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 was supported by data from a late-stage clinical trial, which indicated that Spravato as a standalone treatment alleviated symptoms as early as 24 hours post-treatment and continued to do so for at least four weeks.
Spravato is administered as a nasal spray and must be taken under healthcare supervision. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances levels of glutamate, the most prevalent neurotransmitter in the brain, facilitating communication between neurons.
In financial highlights, sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in 2023. The drug has been utilized by 100,000 patients across 77 countries, as reported by Johnson & Johnson.