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 administered as a standalone treatment for individuals with treatment-resistant depression.
Spravato was originally approved by the FDA in 2019 for use alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants. Johnson & Johnson highlighted that nearly 30 percent of the approximately 280 million people worldwide diagnosed with major depressive disorder suffer from 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 is supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, can alleviate symptoms as quickly as 24 hours after administration and maintain efficacy for at least four weeks.
Spravato is delivered via a nasal spray and must be administered under the supervision of a healthcare provider in a clinical environment. In contrast to other antidepressants that target chemicals like serotonin and dopamine in the brain, Spravato enhances glutamate levels. Glutamate, the brain’s most prevalent neurotransmitter, is crucial for neuronal communication.
Sales for Spravato increased by 60% to reach $271 million during the quarter ending June 30, compared to the same period in 2023. The medication has been utilized by over 100,000 patients across 77 countries, according to Johnson & Johnson.