Tonix Pharmaceuticals Completes Enrollment in Phase 2 Clinical Study of TNX-201 in Episodic Tension-Type Headache

Tonix Pharmaceuticals Holding Corp. TNXP ("Tonix"), which is developing next-generation medicines for fibromyalgia, post-traumatic stress disorder (PTSD), and episodic tension-type headache, today announced it has completed patient randomization in its Phase 2 proof-of-concept (POC) clinical study of TNX-201 (dexisometheptene mucate) in episodic tension-type headache. "TNX-201, representing a new class of analgesics, could offer advantages over currently-approved products for episodic tension-type headache. All of the existing prescription medications contain barbiturates, which are not recommended for extended use due to their potential for tolerance, dependence, and addiction," said Seth Lederman, M.D., Tonix's president and CEO. "Our current proof-of-concept study is designed to evaluate the activity of TNX-201 using several different efficacy measures, as well as safety and tolerability," added Dr. Lederman. "We expect to report top-line results of this study in the first quarter of 2016." The Phase 2 POC study is a randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of a single 140 mg dose of TNX-201 versus placebo for the treatment of a single tension-type headache. Approximately 150 headache events will be investigated. This study will assess the efficacy of TNX-201 on headache pain according to a variety of measures, including: the proportion of patients reported to be pain-free at several time intervals as assessed on a four-point Numeric Rating Scale (NRS), Visual Analog Scale (VAS), and binary questionnaire for self-reporting pain; the proportion of patients who use rescue medication during the 24-hour post-dose period; and the change from baseline pain severity at several time intervals. The performance of TNX-201 across these measures will guide Tonix's selection of appropriate and U.S. Food and Drug Administration (FDA)-accepted efficacy endpoints for future clinical trials. Episodic tension-type headache affects approximately 75 million people in the U.S. and is estimated to be three times as prevalent as migraine. Approximately 21 million prescriptions are filled for acute treatment of non-migraine headache each year, including approximately 3.5 million prescriptions for butalbital combination products, the only prescription products approved for episodic tension-type headache. To learn more about Tonix's Phase 2 POC study with TNX-201 in episodic tension-type headache, please visit www.clinicaltrials.gov (NCT02423408).