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, as a standalone treatment for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato is currently indicated for use in conjunction with an oral antidepressant for patients who have not experienced improvement with two or more other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide suffering from major depressive disorder have treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated, “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 accompanied by data from a late-stage clinical trial, which demonstrated that Spravato, when used as a single treatment, began to alleviate patient symptoms as soon as 24 hours after administration and continued to do so for at least four weeks.
Spravato is delivered as a nasal spray and must be taken in the presence of a healthcare provider within a clinical setting. Unlike traditional antidepressants that target chemicals such as serotonin and dopamine in the brain, Spravato operates by enhancing glutamate levels. Glutamate is the most prevalent neurotransmitter in the brain and plays a crucial role in the communication between neurons.
Sales for Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in the previous year. The drug has been utilized by 100,000 individuals across 77 countries, according to Johnson & Johnson.