Tonix Pharmaceuticals Holding Corp. (OTCBB:TNXP) ("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"), will initiate a comparative pharmacokinetic ("PK") and bioavailability ("BA") study of TNX-102, a novel dosage oral formulation of cyclobenzaprine for the treatment of FM, following the U.S. Food and Drug Administration ("FDA") clearance of the Company's initial Investigational New Drug Application. TONIX also received clearance from Health Canada, which issued a No Objection Letter to the Company's Clinical Trial Application.
This comparative PK/BA study is expected to enroll approximately 30 healthy adult volunteers to participate in a single-dose, open-label, randomized three-way-crossover study. The study will compare a TNX-102 candidate gelcap containing a very low dose (2.4 milligrams) of cyclobenzaprine to a currently available, immediate-release, 5 milligram cyclobenzaprine tablet. In addition, the effect of food on the PK of TNX-102 will be investigated in subjects who are either fasting or fed with a high-fat, high-caloric breakfast. The study will measure each subject's circulating blood levels of cyclobenzaprine over time in each condition. A leading global clinical research organization based in Canada will be conducting the study in Quebec City, Quebec, Canada. TONIX anticipates the clinical portion of the study will be completed by year-end, and that analysis of the subjects' blood samples will be completed in early 2012.
Seth Lederman, M.D., Chairman and President of TONIX said, "The objective of this PK study is to compare the PK profile of our proprietary gelcap formulation, TNX-102, to a conventional immediate-release formulation. Immediate release cyclobenzaprine results in relatively steady blood levels over the course of the day, which is ideal for the treatment of muscle spasm, its approved indication. TNX-102 is specifically formulated to work at night after bedtime administration. If this study validates our hypothesis, we will proceed with the first of our two pivotal clinical trials. Our successful Phase 2a proof-of-concept study, which used an immediate release capsule formulation of very low dose cyclobenzaprine, showed FM patients benefitted from bedtime very low dose cyclobenzaprine and that improvements were correlated with increased nights of restorative sleep. Our goal is to develop a bedtime cyclobenzaprine treatment with more predictable beneficial effects and possibly reduced next day drowsiness."
The results of the Phase 2a study were recently published in the electronic edition of the Journal of Rheumatology and can be accessed at http://jrheum.org/content/early/2011/08/30/jrheum.110194.full.pdf+html.