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-derived medication, Spravato, allowing it to be utilized as a standalone treatment for patients with treatment-resistant depression.
Spravato received initial FDA approval in 2019 for use in conjunction with an oral antidepressant for individuals whose symptoms did not improve following two or more antidepressant therapies.
The company highlighted that nearly 30 percent of the estimated 280 million people globally who suffer from 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 new application incorporates data from a late-stage clinical study that indicated Spravato as a standalone treatment could alleviate symptoms within 24 hours and sustain that relief for at least four weeks.
Spravato is delivered via nasal spray and must be administered under the supervision of a healthcare professional in a clinical environment. Unlike typical antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter in the brain and is essential for neuronal communication.
Sales for Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same timeframe in 2023. Johnson & Johnson reported that the drug has been utilized by 100,000 patients across 77 countries.