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BioSpecifics Technologies Corp Announces Positive Top-Line Data From XIAFLEX MULTICORD Phase IIIb Study

Monday, 18 Nov 2013 08:30am EST 

BioSpecifics Technologies Corp announced positive results from the open label, Phase IIIb MULTICORD (Multiple Treatment Investigation of Collagenase Optimizing the Resolution of Dupuytren's) study evaluating XIAFLEX for the concurrent treatment of adult Dupuytren's contracture patients with multiple palpable cords. The study demonstrated that two concurrent injections of XIAFLEX 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. Adverse event (AE) rates were also comparable to single injection administration 30 days apart. This study was conducted by BioSpecifics' partner Auxilium Pharmaceuticals, Inc. (Auxilium) and is the interventional clinical study for the treatment of Dupuytren's contracture to date. Based on these results along with those from earlier MULTICORD studies, Auxilium expects to submit the planned supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) in the first quarter of 2014 seeking expansion of the labeling for the concurrent treatment of multiple palpable cords. In this global, multicenter open label Phase IIIb MULTICORD study, 715 patients received two concurrent injections of 0.58 mg of XIAFLEX into cords of two affected joints in the same hand. 

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1 May 2015