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Thursday, November 18, 2010

TONIX Pharmaceuticals : Analysis of Phase 2a Study of Very Low Dosage Cyclobenzaprine in Fibromyalgia Syndrome (FMS)

TONIX Pharmaceuticals (formerly known as Krele Pharmaceuticals)November 9, 2010 – For the First Time, Correlation Demonstrated between Sleep Stability and Reductions of Fatigue in FMS - Results Presented at the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) 2011 Annual Scientific Meeting - TONIX Pharmaceuticals (formerly known as Krele Pharmaceuticals), a specialty central nervous system (CNS) pharmaceutical company, announced results of a new analysis of a Phase 2a study, which previously demonstrated reduced pain, fatigue and tenderness in patients with Fibromyalgia Syndrome (FMS) following bedtime administration of very low dosage (VLD) cyclobenzaprine (CBP). According to the analysis, VLD CBP treatment was associated with reductions in an objective measure of non-REM sleep instability, referred to as Cyclic Alternating Patterns (CAP) A2 & A3; these reductions were statistically significantly correlated with diminished pre-sleep/p.m. fatigue in FMS. The findings are the subject of a poster presentation at the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) 2011 Annual Scientific Meeting.

Dr. Harvey Moldofsky, President and Medical Director, Centre for Sleep and Chronobiology, Toronto, Canada, and lead author of the study, commented, “Current treatments for FMS are inadequate, and there is substantial interest in the impact of improving sleep quality in these patients. Our analysis demonstrates improvements in FMS fatigue can be correlated with a therapeutic modality that normalizes nonrestorative sleep, and we believe this provides additional confirmation of the central importance of poor sleep quality in FMS.”... TONIX Pharmaceuticals' Press Release -