- Published on Tuesday, 24 July 2012 16:03
- Written by Small Sector
NEW YORK, Jun 27, 2012 (BUSINESS WIRE) -- Tonix Pharmaceuticals Holding Corp. TNXP -1.00% ("TONIX" or the "Company"), a specialty pharmaceutical company developing therapies for challenging disorders of the central nervous system ("CNS") including fibromyalgia syndrome ("FM") and post-traumatic stress disorder ("PTSD"), announces that the Company will initiate a comparative study on a novel treatment for FM that targets sleep problems associated with chronic pain syndromes. TONIX's new approach is opiate-free and non-addictive. Health Canada has provided TONIX with clearance for a comparative pharmacokinetic ("PK") and bioavailability ("BA") study of TNX-102, the Company's novel oral formulation of cyclobenzaprine for the treatment of FM. Health Canada has issued a No Objection Letter to TONIX's Clinical Trial Application. Cyclobenzaprine is the active ingredient in two U.S. FDA- and Health Canada-approved prescription muscle relaxants that are marketed by other companies. Seth Lederman, M.D., Chairman and President of TONIX said, "FM patients are desperate to get a good night's sleep because many have learned that restorative sleep can improve their pain and fatigue. We have designed TNX-102 to work at night after bedtime administration. We expect the results of this PK study will corroborate studies done in animals, and we will use the findings to finalize our commercial formulation for pivotal clinical studies." Dr. Lederman also said, "The objective of this study is to compare the PK profile of our proprietary TNX-102 formulation with the PK of a conventional immediate release formulation and the PK of an intravenous injection." In addition, Dr. Lederman noted, "Immediate release cyclobenzaprine results in relatively steady blood levels over the course of the day, which is ideal for the treatment of muscle spasms, its approved indication. In our Phase 2a study, bedtime administration of very low dose cyclobenzaprine capsules improved core FM symptoms including pain, tenderness, fatigue and depression. This study also demonstrated that those improvements were correlated with increased nights of restorative sleep. Our goal is to develop a bedtime cyclobenzaprine treatment with more predictable beneficial effects and reduced next-day somnolence compared with the current doses and formulations of cyclobenzaprine." The study will be conducted in Canada by a leading global clinical research organization. TONIX anticipates the clinical portion of the study to be completed by the end of July, with analysis of the subjects' blood samples to be completed before September 30, 2012. TONIX's comparative PK/BA study is expected to enroll approximately 15 healthy adult volunteers to participate in a single-dose, open-label, randomized study. The three arms will compare a TNX-102 candidate tablet in a novel formulation containing a very low dose (2.4 mg) of cyclobenzaprine with a currently available, immediate release, 5 milligram cyclobenzaprine tablet and with intravenous cyclobenzaprine, which is considered a standard for BA studies. The study will measure each subject's circulating blood levels of cyclobenzaprine over time in each condition. TONIX also plans to use new doses and formulations of cyclobenzaprine in a new treatment for PTSD, in addition to FM.