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 allow it to be utilized as a standalone therapy for individuals suffering from treatment-resistant depression.
The FDA initially authorized Spravato in 2019 for use alongside an oral antidepressant in patients whose symptoms did not improve after trying two or more antidepressants. The company highlighted that nearly 30% of the approximately 280 million individuals globally diagnosed 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 to the FDA was backed by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, began to alleviate patients’ symptoms within 24 hours and sustained this relief for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare professional in a medical setting. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate, the brain’s most prevalent neurotransmitter, plays a crucial role in neuronal communication.
Sales of Spravato surged by 60% to reach $271 million in the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson reported that the medication has been used by 100,000 patients across 77 countries.