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Tonix Pharmaceuticals Reports Improvement in “Brain Fog,” in Fibromyalgia Patients Treated with Tonmya™ in RESILIENT, an NDA-Enabling Phase 3 Clinical Trial, at the 6th International Congress on Controversies in Fibromyalgia
Phase 3 RESILIENT study of Tonmya met its primary endpoint of daily pain reduction (p=0.00005) and achieved statistically significant improvement on all six
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"Phase 3 RESILIENT study of Tonmya met its primary endpoint of daily pain reduction (p=0.00005) and achieved statistically significant improvement on all six key pre-specified secondary endpoints with effect sizes on sleep, fatigue, FIQ-R symptoms and FIQ-R function ranging from 0.3 to 0.5 Cognitive dysfunction, or “brain fog,” nominally improved on FIQ-R memory item (p=0.001) where the patients rated their level of memory problems NDA submission expected in the second half of 2024 following pre-NDA meeting with FDA scheduled for the second quarter of 2024 CHATHAM, N.J., March 11, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the presentation of additional efficacy data from RESILIENT, the second positive Phase 3 study evaluating Tonmya (also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia, at the 6th International Congress on Controversies in Fibromyalgia in Brussels, Belgium, March 7-8, 2024. In presenting more detailed data from the RESILIENT study, Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, said, “We previously reported statistically significant and clinically meaningful results in all six key secondary endpoints related to improving sleep quality, reducing fatigue, and improving overall fibromyalgia symptoms and function. We now report that the effect sizes of the five continuous key secondary outcomes measures ranged from 0.3 to 0.5. The results also showed that Tonmya treatment resulted in an improvement in cognitive dysfunction, or ‘brain fog’, measured by the change in the Fibromyalgia Impact Questionnaire-Revised (FIQ-R) memory item. The FIQ-R cognitive item showed nominal improvement in Tonmya-treated patients vs placebo-treated patients with a p=0.001 and effect size of 0.31. Together, we believe the activity of Tonmya on pain, sleep quality, fatigue and brain fog are indicative of broad-spectrum activity of Tonmya and suggest that Tonmya treats fibromyalgia at a syndromal level.” As previously announced, RESILIENT met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. RELIEF, the firs...