Xiaflex (Auxilium) benefits multiple Dupuytren's Contractures
Results of the MULTICORD open-label Phase IIIb study (AUX-CC-867) demonstrated that two concurrent injections of Xiaflex (collagenase clostridium histolyticum or CCH), from Auxilium Pharma, in patients with multiple Dupuytren's Contractures resulted in comparable improvement in joint contracture and range of motion to those seen in previous studies when Xiaflex was administered as single injections, 30 days apart.
The study found that concurrent injections reduced total fixed flexion contracture by an average of 74.4% and improved the total range of motion by a combined average 66.6 degrees. Hand functionality as measured by the URAM scale improved an average of 12.3 points. The estimated clinically important change of the URAM scale is 2.9 points.
The most common treatment-related AEs were mild or moderate and consistent with those seen in the studies utilizing single injections. The most common were swelling, contusion and pain in extremity. The company expects to submit supplemental Biologics License Application to the FDA in Q1 of 2014.
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