Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based drug, Spravato, allowing it to be utilized as a standalone therapy for treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was designed to be administered alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressant medications. It is noteworthy that nearly 30% of the approximately 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression, as reported by Johnson & Johnson.
Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized the struggles faced by patients with hard-to-treat depression, noting the lengthy process of trying multiple treatments that often fail to alleviate symptoms. This situation not only affects the patients but also significantly impacts their families.
The submission includes findings from a late-stage clinical trial that demonstrated that Spravato, when used alone, could start alleviating symptoms as soon as 24 hours post-treatment, with effects lasting for at least four weeks.
Spravato is delivered as a nasal spray, and its use must occur under the supervision of a healthcare provider in a clinical setting. Unlike conventional antidepressants that adjust serotonin and dopamine levels, Spravato operates by increasing glutamate levels in the brain, which is essential for effective neuronal communication.
Sales of Spravato have seen a remarkable increase, rising by 60% to $271 million for the three months ending June 30, compared to the same period last year. Additionally, the medication has reached around 100,000 patients in 77 countries, pointing to its growing acceptance and usage.
This development marks a significant step forward in providing hope to those suffering from treatment-resistant depression, potentially offering a viable solution where conventional treatments have failed. Johnson & Johnson’s ongoing commitment to innovative mental health therapies reflects a broader trend within the healthcare industry to prioritize effective treatment options for challenging conditions.