Tonix Pharmaceuticals Holding Corp, a clinical-stage firm currently advancing next-generation medicines to address the unmet needs related to post-traumatic stress disorder, fibromyalgia, and episodic tension-type headache, recently announced that two of the company’s abstracts were accepted and will be presented at the European League Against Rheumatism Annual Congress (EULAR 2015) in Rome, Italy. The studies that will be presented will cover the efficacy of TNX-102 SL to treat patients with fibromyalgia.
Fibromyalgia symptoms include chronic musculoskeletal pain, incapacitating fatigue, stiffness and numbness in certain parts of the body, painful response to pressure, headaches, unrefreshing sleep (poor sleep quality), anxiety or depression and mood alterations. The disease can compromise the ability to perform simple daily tasks and estimates say that 5 to 15 million Americans are affected by this disorder, especially women.
The two accepted abstracts are “TNX-102 SL for Treatment of Fibromyalgia: Approaches to Pain Measurement” to be presented by R. Michael Gendreau, M.D., Ph.D., Principal, Gendreau Consulting on June 11 between 12:00 p.m. and 1:45 p.m; and “TNX-102 SL for the Treatment of Fibromyalgia: Role of Nonrestorative Sleep on Pain Centralization” that will be presented by Seth Lederman, M.D., CEO, Tonix Pharmaceuticals on June 11 between 12:00 p.m. and 1:45 p.m. More details about these presentations can be found at www.congress.eular.org.
TNX-102 SLAttribution (cyclobenzaprine HCl sublingual tablet) is Tonix’s lead product candidate being advanced to become a standard step towards improved sleep and pain management for those struggling with both fibromyalgia and post-traumatic stress disorder (PTSD). TNX-201 is being advanced also to address episodic tension-type headache, which is the most frequent form of headache.
Additionally, TNX-102 SL is currently being assessed in the Phase 3 AFFIRM project for fibromyalgia and in the Phase 2 AtEase project to address post-traumatic stress disorder. In the second quarter of 2015, a Phase 2 proof-of-concept study of TNX-201 for episodic tension-type headache will initiate.
The goal of this Phase 3 randomized, double-blind, placebo-controlled AFFIRM trial is to evaluate the safety and efficacy of sublingual TNX-102 SL tablet taken daily for a 12-week treatment period. Researchers will assess improvement in sleep quality, pain, and other clinical indicators. The primary efficacy outcome assessment for this trial is a pain responder analysis, which was established as the proportion of patients who report at least a 30% decrease in pain at the end of the study. Results on the AFFIRM trial are expected in the second half of 2016.
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