Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based medication, Spravato, to be utilized as a standalone therapy for treatment-resistant depression.
Spravato was first 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. The company highlighted that nearly 30 percent of the approximately 280 million individuals globally affected by major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, expressed in a press release that many patients enduring difficult-to-treat depression often face prolonged periods of trying various treatments that fail to alleviate their symptoms, resulting in significant emotional and functional challenges for both patients and their families.
The application is supported by findings from a late-stage clinical trial which revealed that Spravato, when used as a standalone treatment, effectively alleviated patients’ symptoms as soon as 24 hours post-treatment and maintained that improvement for at least four weeks.
Spravato is administered via nasal spray and requires supervision from a healthcare provider in a healthcare environment. Unlike traditional antidepressants that primarily target brain chemicals such as serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, which is the predominant neurotransmitter facilitating neuronal communication.
In terms of financial performance, sales of Spravato surged by 60% to $271 million for the quarter ending June 30, compared to the same timeframe in the previous year. To date, the medication has been utilized by 100,000 individuals in 77 countries, according to Johnson & Johnson.