Johnson & Johnson announced on Monday that it has filed a request with the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-derived medication, Spravato, as a standalone treatment for individuals with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designated for use alongside an oral antidepressant for patients who had not found relief with two or more other antidepressants.
Johnson & Johnson noted that nearly 30 percent of the approximately 280 million individuals globally living with major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized 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, leading to significant functional and emotional burdens on patients and their families.”
The application for the expanded use of Spravato was supported by data from a late-stage clinical trial, which indicated that the medication could alleviate patients’ symptoms within 24 hours of administration and continued to have effects for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a medical environment. Unlike traditional antidepressants that target brain chemicals like serotonin and dopamine, Spravato enhances glutamate, the most prevalent neurotransmitter in the brain, facilitating neuronal communication.
In a financial report, Johnson & Johnson revealed that sales of Spravato surged 60% to $271 million in the second quarter of 2023 compared to the same period in the previous year. The medication has been utilized by around 100,000 patients across 77 countries.