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 administered as a standalone therapy for individuals suffering from treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide who suffer from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, commented 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 was backed by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, alleviated patients’ symptoms as soon as 24 hours post-treatment and maintained efficacy for at least four weeks.
Spravato is administered via nasal spray and must be taken under the supervision of a healthcare provider in a medical setting. Unlike traditional antidepressants that modify neurotransmitters like serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter in the brain and facilitates communication between neurons.
Sales of Spravato surged by 60% to $271 million during the three-month period ending June 30, compared to the same timeframe in 2023. The medication has been utilized by 100,000 individuals across 77 countries, according to Johnson & Johnson.