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, to function as a standalone treatment for those with treatment-resistant depression.
The FDA initially approved Spravato in 2019 for use alongside an oral antidepressant for patients whose condition did not improve with two or more prior antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide suffering from 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 application to the FDA was supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, could alleviate patients’ symptoms as soon as 24 hours after administration and maintain these improvements for at least four weeks.
Spravato is delivered as a nasal spray and is required to be administered under a healthcare provider’s supervision in a medical setting. Unlike traditional antidepressants that target brain chemicals such as serotonin and dopamine, Spravato enhances the levels of glutamate in the brain, which is the most prevalent neurotransmitter and vital for neuron communication.
In terms of financial performance, sales of Spravato increased by 60% to $271 million for the quarter ending June 30, compared to the same quarter in 2023. The drug has been utilized by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.