Abstract

s / Osteoarthritis and Cartilage 22 (2014) S57–S489 S377 ECGs and vital signs were unremarkable and similar across all treatments. Plasma TCA concentration across the FX006 doseswere linear and dose-dependent. Peak plasma concentrations achieved with 40 mg TCA IR were 10X of those seen with FX006 40 mg. Conclusions: It is demonstrated that sustained residency of TCA in the joint prolongs therapeutic effect. The 40 mg dose of FX006 produced an effect atWeek 12 ( 3.7) that was equivalent to the maximal effect of TCA IR at Week 4. Surprisingly, between Weeks 2 and 11, the analgesic effect of the 40mg dose of FX006 exceeded themaximal effect of TCA IR seen at Week 4. This observation suggests that prolonged occupation of the corticosteroid receptor may be associated with an enhanced analgesic effect. Further, this amplification of effect may constitute a meaningful clinical improvement relative toTCA IR as indicated by the 20% responder analysis for the 40 mg dose of FX006. A study is underway to determine the TCA concentrations in the joint at varying time points, and subsequent studies against placebo will define effect size and duration of action. Figure 1. Weekly Mean of Average Daily Pain Score (ADP) Figure 2. Proportion of Responders, >20% Improvement

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