Tonix Pharmaceuticals Holding Corp. held a key opinion leader (KOL) webinar to discuss the positive Phase 3 data of Tonmya? (also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia, and the path to file for FDA approval in the second half of 2024.

The webinar was held on January 31, 2024 and hosted by Alliance Global Partners (A.G.P.). The webinar featured two thought leaders in the field of fibromyalgia: Daniel Clauw, M.D., Professor of Anesthesiology, Medicine and Psychiatry, Director Chronic Pain & Fatigue Research Center, University of Michigan, and Lesley Arnold, M.D., Professor of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine. Tonmya?

is a centrally acting, non-opioid, non-addictive, bedtime medication. As previously announced, Tonix?s second positive Phase 3 study, RESILIENT, met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results (p=0.001 or better) were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue, and improving overall fibromyalgia symptoms and function.

Tonix plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2024 for Tonmya? for the management of fibromyalgia.