Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based medication, Spravato, for treatment-resistant depression as a standalone therapy.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant in patients who had not responded to two or more antidepressants. The company highlighted that nearly 30 percent of the estimated 280 million individuals globally living with 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 was supported by data from a late-stage clinical trial indicating that Spravato, used independently, could alleviate symptoms within 24 hours after administration and maintain that relief for at least four weeks.
Spravato is delivered as a nasal spray and must be taken in a healthcare setting under the supervision of a provider. Unlike conventional antidepressants that target brain chemicals such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter and plays a crucial role in neuronal communication.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30 compared to the same period in 2022. The drug has been utilized by over 100,000 patients across 77 countries, according to the company.