NEW YORK, NY--(Marketwired - October 24, 2013) - Tonix Pharmaceuticals Holding Corp. (TNXP), a development stage specialty pharmaceutical company, has become a corporate partner of the American Chronic Pain Association (ACPA) as part of its efforts to help raise awareness about fibromyalgia.
"The American Chronic Pain Association is dedicated to updating the public regarding the research and treatment for chronic pain in its many forms," said Seth Lederman, M.D., CEO and President of Tonix. "Fibromyalgia is believed to affect approximately five million people in the U.S., and this syndrome is increasingly identified in people who suffer chronic pain. We are confident that this partnership will continue to bring greater recognition to fibromyalgia and provide an opportunity to report Tonix's clinical progress to those who may need it most."
Tonix is currently developing TNX-102 SL, its lead clinical candidate for the treatment of fibromyalgia and post-traumatic stress disorder. The Company recently announced the initiation of its BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT) clinical trial, which is the first of two anticipated pivotal trials for TNX-102 SL 2.8 mg tablets in patients with fibromyalgia.
"We continue to strive to provide the best possible support, education in pain management skills, and resources to those who experience chronic pain in whatever form it takes," said Penney Cowan, Executive Director and Founder of the ACPA. "Partnerships with companies such as Tonix provide us with an important opportunity to inform consumers about the many elements of multidisciplinary pain management so that they may regain a sense of control in their lives and hope for their future."
In April of this year, the United States Food and Drug Administration (FDA) selected fibromyalgia as a disease on which to focus for the next two fiscal years. The FDA will be conducting a public meeting on December 10, 2013 under Patient-Focused Drug Development, an initiative that involves obtaining a better understanding of patients' perspectives on the severity of the disease and the available therapies for the condition. These activities demonstrate an increased awareness of fibromyalgia and its impact among the U.S. population.
About Tonix Pharmaceuticals Holding Corp.
Tonix is developing innovative prescription medications for challenging disorders of the central nervous system. Tonix seeks to address conditions characterized by significant unmet medical need, inadequate existing treatment options, and high dissatisfaction among patients and physicians. Tonix's lead pharmaceutical candidate, TNX-102 SL, targets central pain. Fibromyalgia is a central pain syndrome, and central pain is a component of post-traumatic stress disorder. Tonix applies its core technology toward the treatment of people suffering from central pain disorders by targeting their inability to obtain restorative sleep. To learn more, please visit www.tonixpharma.com.
About the American Chronic Pain Association
The American Chronic Pain Association was founded in 1980 by Penney Cowan in Pittsburgh, Pennsylvania. After many years of living with chronic pain, Penney had taken part in the pain management program at the Cleveland Clinic and was eager to maintain the skills she had learned there when she returned to her daily life.
Penney placed a notice in her church bulletin and soon found others whose lives were compromised by ongoing pain. They began meeting as the first ACPA support group. This one small group quickly became many. Unable to be personally involved with every group, Penney developed the first of the ACPA's manuals and other materials so that others could learn and maintain the skills that had been so important to maintaining her wellness.
Today several hundred ACPA support groups meet across the U.S. and in Canada, Great Britain, and many other countries. The ACPA's unique materials are a primary resource for individuals seeking to improve the quality of their lives and for the professionals who help them. To learn more, please visit www.theacpa.org.
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," "estimate" 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 11, 2013 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.