BioSpecifics Technologies announced positive results from its Phase 3b MULTICORD study evaluating Xiaflex (collagenase clostridium histolyticum) for the concurrent treatment of adult Dupuytren’s contracture patients with multiple palpable cords.
In this global, multicenter open label MULTICORD (Multiple Treatment Investigation of Collagenase Optimizing the Resolution of Dupuytren’s) study, 715 patients received two concurrent injections of Xiaflex 0.58mg into cords of two affected joints in the same hand.
The study found that concurrent injections of Xiaflex 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 (Unite Rhumatologique des Affections de la Main) scale, a 9-item validated scale developed to assess functional outcome of patients suffering from Dupuytren’s disease, improved an average of 12.3 points. The estimated clinically important change of the URAM scale is 2.9 points.
Researchers also examined the timing of the finger extension procedure. Currently Xiaflex injection is followed by the finger extension procedure at 24 hours when needed. In the MULTICORD study, finger extension was performed at 24, 48 or 72 hours. There was no difference in the efficacy or safety profile based upon finger extension times.
Based on these results along with those from earlier MULTICORD studies, Auxilium expects to submit a supplemental Biologics License Application (sBLA) to the FDA in the first quarter of 2014 seeking expansion of the Xiaflex labeling for the concurrent treatment of multiple palpable cords. Xiaflex is already approved for Dupuytren’s contracture with a palpable cord.
For more information call (516) 593-7000 or visit BioSpecifics.com.