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 used as a standalone treatment for individuals suffering from treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designed to be used in conjunction with an oral antidepressant for patients who did not see improvements after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30% of the estimated 280 million people worldwide living with major depressive disorder are affected by treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release that “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 based on data from a late-stage clinical trial showing that Spravato, when used as a standalone treatment, began alleviating symptoms in patients as early as 24 hours after administration, with effects lasting for at least four weeks.
Spravato is delivered as a nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike typical antidepressants that target brain chemicals like serotonin and dopamine, Spravato enhances the activity of glutamate, the most abundant neurotransmitter in the brain, thus improving neuronal communication.
Sales of Spravato experienced a significant increase, rising 60% to $271 million for the quarter ending June 30 compared to the same period in the previous year. The medication has been utilized by approximately 100,000 individuals across 77 countries, as reported by Johnson & Johnson.