VLD cyclobenzaprine: Phase IIa data

Tonix and researchers at the University of Toronto reported data from a double-blind Phase IIa trial in 36 patients with fibromyalgia syndrome and disturbed sleep showing that 1-4 mg VLD cyclobenzaprine given at bedtime significantly improved musculoskeletal pain by 18.2%, tenderness by 16.7% and HAD scale scores by 38.5% relative to placebo at week 8 (p=0.04, p=0.03 and p=0.02, respectively). VLD cyclobenzaprine non-significantly improved fatigue by 12.4% relative to placebo at week 8 (p=0.13). Additionally, a significantly greater proportion of patients treated with VLD cyclobenzaprine had increased nights of restorative sleep as determined by an analysis of cyclical alternating pattern sleep EEG vs. placebo. VLD cyclobenzaprine given at bedtime was well tolerated with no serious adverse events or discontinuations due to adverse events. Data were published in the Journal of Rheumatology. ...