New Approach to Treating Fibromyalgia by Addressing Sleep Problems Leads to Patient Improvement
NEW YORK--(BUSINESS WIRE)--Tonix Pharmaceuticals Holding Corp. (OTCBB: TNXP) (“TONIX” or the “Company”), which specializes in non-addictive treatments for chronic pain syndrome disorders, announces that Chief Executive Officer Seth Lederman, M.D. was interviewed by GLX-TV Financial News. In providing an eight-minute overview of the Company, Dr. Lederman stated that TONIX is focused on treating fibromyalgia pain in an entirely new, opiate-free approach that targets sleep problems associated with chronic pain syndromes. Dr. Lederman’s full interview as part of the GLX-TV OpenCEOLive series is available at https://www.youtube.com/watch?v=l8hb2E5CO0k&feature=player_embedded.
Dr. Lederman noted that by treating sleep problems in fibromyalgia patients, symptoms of the entire syndrome improve. He pointed out that opiate addiction is a major problem among chronic pain sufferers and acknowledged that fibromyalgia has not been optimally treated by the medical community. The National Institutes of Health estimates that there are five million Americans with fibromyalgia, Dr. Lederman said. He added that the growing drug market for fibromyalgia is $1.2 billion a year and that only the U.S. and Canada have approved drugs to treat fibromyalgia. Only three drugs are indicated for fibromyalgia, none of which have been shown to address the underlying sleep disturbance that is a hallmark of the disorder.
TONIX plans to use a proprietary, low dose formulation of cyclobenzaprine in a new treatment paradigm for fibromyalgia and post-traumatic stress disorder (PTSD). Cyclobenzaprine is the active ingredient in two prescription muscle relaxants that have been approved by the U.S. Food and Drug Administration and are marketed by other companies.
Dr. Lederman noted that the recent contraction in research and development by large pharmaceutical companies provides opportunities for companies such as TONIX that pursue innovative approaches to treating unmet medical needs, with the goal of partnering with larger firms for late-stage development, marketing and distribution.
TONIX is a patient-focused company led by an experienced management team with a distinguished track record in drug development. The Company’s Board of Directors includes Samuel R. Saks, M.D. who developed pharmaceutical products for central nervous system conditions, including Xyrem® and Concerta®, and is the former CEO and founder of Jazz Pharmaceuticals, Inc.
Prior to founding TONIX, Dr. Lederman co-founded and was a managing partner of Konanda Pharma Partners, LLC and Konanda Pharma Fund I, LP. He co-founded and served as chairman of its wholly owned operating companies, Validus and Fontus Pharmaceuticals Inc. In 2000, Dr. Lederman founded Targent Pharmaceuticals to develop late-stage oncology drugs. In 1998, he co-founded Vela Pharmaceuticals, which developed several drugs for central nervous system disorders, including very low dose cyclobenzaprine.
TONIX is developing innovative prescription medications for challenging disorders of the central nervous system. The Company targets conditions characterized by significant unmet medical need, inadequate existing treatment options, and high dissatisfaction among both patients and physicians. TONIX’s core technology improves the quality of sleep in patients with chronic pain syndromes. TONIX’s lead products are designed to be fundamental advances in sleep hygiene and pain management and to be safer and more effective than currently available treatments. TONIX’s products are the result of a program to harvest advances in science and medicine to search for potential therapeutic solutions among known pharmaceutical agents. TONIX is developing new formulations that have been optimized for new therapeutic uses. Its most advanced product candidates, TNX-102 for fibromyalgia and TNX-105 for PTSD, are novel dosage formulations of cyclobenzaprine, the active ingredient in two U.S. FDA-approved muscle relaxants. To learn more about the Company and its pipeline of treatments for central nervous system conditions, please visit www.tonixpharma.com.
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated" and "intend," among others. These forward-looking statements are based on TONIX’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. TONIX does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K filed with the SEC on March 30, 2012 and future periodic reports filed with the Securities and Exchange Commission. All of the Company's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date hereof.