TNX-102 SL Data Presented at AAPM

A copy of the Company’s poster, titled “Sublingual Cyclobenzaprine (TNX 102 SL) for Fibromyalgia: Efficacy and Safety in Two Randomized, Placebo-Controlled Trials” is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.

“Designed as a bedtime treatment to target non-restorative sleep and provide durable benefits, TNX 102 SL has shown statistically significant, robust activity in reducing fibromyalgia pain in two pivotal Phase III studies,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Fibromyalgia has historically been overlooked and unrecognized as a chronic pain condition. Patients’ needs have been inadequately addressed by the previously approved products, which results in many patients being prescribed chronic opioids, which are believed to be ineffective, and are instead a deleterious treatment strategy. Designed to address this nociplastic pain, TNX 102 SL now has the potential to be the first new treatment option for fibromyalgia patients in 15 years.”

In two pivotal randomized, placebo-controlled clinical trials, the efficacy of TNX 102 SL (cyclobenzaprine HCl sublingual tablets) was assessed with a primary endpoint of reducing the weekly average of daily pain from baseline after 14 weeks of treatment using the numeric rating scale scores. In both studies, TNX 102 SL significantly reduced pain and improved clinical outcomes in fibromyalgia patients while demonstrating a favorable tolerability profile via a novel mechanism of targeting the sleep disturbance associated with fibromyalgia. TNX 102 SL is a potent antagonist at four post-synaptic receptors, each of which is involved in regulating sleep. TNX 102 SL is designed for rapid, transmucosal absorption and, as demonstrated in pharmacokinetic studies, bypassing first-pass hepatic metabolism resulting in greater bioavailability of cyclobenzaprine that aligns with the sleep cycle to target non-restorative sleep for the purpose of facilitating recovery from the fibromyalgia syndrome.