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 serve as a standalone treatment for individuals with treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was intended for use alongside an oral antidepressant for patients whose symptoms failed to respond to two or more antidepressants. Johnson & Johnson noted that nearly 30 percent of the estimated 280 million individuals globally with major depressive disorder experience 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 company submitted its application with data from a late-stage clinical trial, which indicated that Spravato, when used as a standalone treatment, alleviated symptoms as soon as 24 hours after administration and continued to provide relief for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a clinical environment. Unlike traditional antidepressants that primarily affect chemicals like serotonin and dopamine in the brain, Spravato enhances levels of glutamate. Glutamate is the most prevalent neurotransmitter in the brain, playing a crucial role in neuronal communication.
Sales of Spravato skyrocketed by 60%, reaching $271 million in the quarter ending June 30, compared to the same quarter in 2023. The medication has been accessed by over 100,000 individuals across 77 countries, according to Johnson & Johnson.