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 utilized as a standalone treatment for individuals with treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was intended to be used in conjunction with an oral antidepressant for patients who have not found relief from their symptoms after trying two or more antidepressants.
Approximately 30 percent of the estimated 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression, according to Johnson & Johnson.
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 for expanded use was supported by data from a late-stage clinical trial showing that Spravato, when used as a standalone treatment, alleviated patients’ symptoms as early as 24 hours after administration and maintained efficacy 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 clinical setting. Unlike other antidepressants that adjust neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter and is crucial for neuron communication.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson reported that the drug has been used by 100,000 individuals across 77 countries.