Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) for the approval of its ketamine-based drug, Spravato, to be utilized as a standalone treatment for individuals suffering from treatment-resistant depression. This expansion aims to provide an alternative option for patients who have not found relief through traditional antidepressant therapies.
Spravato was initially approved by the FDA in 2019, allowing it to be prescribed alongside an oral antidepressant for patients whose depression did not respond to multiple prior treatments. According to Johnson & Johnson, around 30 percent of the estimated 280 million worldwide individuals suffering from major depressive disorder experience treatment-resistant symptoms.
Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients dealing with hard-to-treat depression. He stated that many of these individuals often spend extended periods trying various treatments without success, leading to significant emotional and functional burdens for both them and their families.
The application for standalone use of Spravato is supported by data from a late-stage clinical trial, which indicates that patients experienced symptom relief as early as 24 hours after treatment, with effectiveness lasting for at least four weeks. Administered as a nasal spray in controlled healthcare environments, Spravato differs from typical antidepressants by enhancing glutamate activity in the brain, rather than targeting serotonin or dopamine levels.
The drug has seen impressive financial performance, with sales increasing by 60% to reach $271 million in the second quarter of 2023. Additionally, Spravato has been used by over 100,000 patients across 77 countries.
This development brings hope as it could potentially improve the lives of many individuals struggling with depression who have not responded to conventional treatments. With the ongoing research and expansion of therapeutic options, there is optimism for enhanced support and solutions for patients battling treatment-resistant depression.