CHATHAM, N.J., Jan. 25, 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 a key opinion leader (KOL) webinar to discuss the positive Phase 3 data of TNX-102 SL for the management of fibromyalgia. The webinar will feature two esteemed thought leaders in the field of fibromyalgia and will be hosted by Alliance Global Partners.
KOL Webinar Details | ||
Title: | KOL Discussion on Positive Phase 3 Data and Advantages Over Current Therapies | |
Date: | Wednesday, January 31, 2024, at 1:00 p.m. ET. | |
Participants: | Daniel Clauw, M.D., Professor of Anesthesiology, Medicine and Psychiatry, Director Chronic Pain & Fatigue Research Center | |
Lesley Arnold, M.D., Professor of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine | ||
Seth Lederman, M.D., President and CEO of Tonix Pharmaceuticals | ||
Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals | ||
Webcast link: | Click here to register/join webinar | |
A replay of the webinar will be available under the IR Events tab of the Tonix website at www.tonixpharma.com following the event.
About the Phase 3 RESILIENT Study
The RESILIENT study was a double-blind, randomized, placebo-controlled trial designed to evaluate the efficacy and safety of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia. The two-arm trial randomized 457 participants in the U.S. across 33 sites. The first two weeks of treatment consisted of a run-in period in which participants started on TNX-102 SL 2.8 mg (1 tablet) or placebo. Thereafter, all participants increased their dose to TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) or two placebo tablets for the remaining 12 weeks. The study met the pre-specified primary endpoint of daily diary pain severity score change (TNX-102 SL 5.6 mg vs. placebo) from baseline to Week 14 (using the weekly averages of the daily numerical rating scale scores), analyzed by mixed model repeated measures with multiple imputation (p=0.00005).
For more information, see ClinicalTrials.gov Identifier: NCT05273749.
About Fibromyalgia
Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts an estimated 6 million to 12 million adults in the U.S., the majority of whom are women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently ...