Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the usage of its ketamine-based medication Spravato, aiming for it to be approved as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially authorized by the FDA in 2019, but only for use in conjunction with an oral antidepressant for patients who had not seen improvement after trying two or more antidepressants.
The company noted that nearly 30 percent of the approximately 280 million people globally affected by 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 submission for expanded use is supported by data from a late-stage clinical trial, which indicated that Spravato could alleviate symptoms as quickly as 24 hours post-treatment and maintain effects 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 environment. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato operates by enhancing glutamate levels in the brain, a crucial neurotransmitter that facilitates communication between neurons.
In sales figures, Spravato saw a remarkable 60% increase, reaching $271 million in the quarter ending June 30, compared to the same timeframe in 2023. Johnson & Johnson reports that the treatment has been utilized by 100,000 individuals across 77 countries.