Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to allow its ketamine-based medication, Spravato, to be used as a standalone treatment for treatment-resistant depression. Originally approved by the FDA in 2019, Spravato was designed to be used in conjunction with an oral antidepressant for patients who had not found relief after undergoing two or more different antidepressant therapies.
According to Johnson & Johnson, around 30 percent of the approximately 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression. Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized the strain that ineffective treatments can impose on patients and their families, highlighting the need for more effective options.
The recent application cites findings from a late-stage clinical trial demonstrating that Spravato, when used alone, could alleviate symptoms as soon as 24 hours after administration and sustain that effect for at least four weeks. Spravato is delivered via nasal spray, requiring administration under the supervision of a healthcare provider.
Notably, sales of Spravato surged by 60% to $271 million in the second quarter of 2023 compared to the same timeframe in the previous year. The medication has made a significant impact, being utilized by around 100,000 patients across 77 countries.
This potential expansion of Spravato’s usage offers hope to countless individuals struggling with difficult-to-treat depression. By potentially providing a new standalone treatment option, Johnson & Johnson is taking a significant step towards improving the quality of life for those who have not found success with existing therapies.