Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval to use its ketamine-based drug, Spravato, as a standalone treatment for individuals with treatment-resistant depression. This move marks a significant step forward for patients struggling with this challenging condition.
Initially approved by the FDA in 2019, Spravato was authorized for use in conjunction with an oral antidepressant for those whose depression did not respond to at least two prior antidepressant treatments. Johnson & Johnson pointed out that nearly 30 percent of the 280 million people worldwide diagnosed with major depressive disorder suffer from treatment-resistant depression, highlighting a substantial need for effective therapeutic options.
Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized the urgency of addressing the difficulties faced by patients enduring tough-to-treat depression: “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 to the FDA was bolstered by data from a recent late-stage clinical trial demonstrating that Spravato, when used alone, can begin alleviating symptoms as soon as 24 hours after administration, and maintain its efficacy for at least four weeks. Spravato is delivered as a nasal spray and requires monitoring by a healthcare professional during treatment. It operates differently from traditional antidepressants, as it enhances glutamate activity in the brain rather than adjusting serotonin or dopamine levels.
Sales figures for Spravato have been promising, soaring 60% to $271 million in the quarter ending June 30, compared to the same period in 2022. The drug is currently being used by approximately 100,000 patients in 77 countries globally.
This development brings hope to millions who are struggling with treatment-resistant depression, as a standalone option may offer them better prospects for management of their condition. If approved, Spravato could significantly improve the quality of life for those who have been ensnared in cycles of ineffective treatments.