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Auxilium Pharmaceuticals Announces Results from Three Year CORDLESS Extension Study in Dupuytren's Contracture
Date:6/30/2011

rmacokinetic study) and received at least one injection of XIAFLEX.  Recurrence in the long-term extension study was standardized and prospectively defined as (a) a joint contracture that was successfully treated (had previously achieved a reduction in contracture to five degrees or less at the Day 30 evaluation after the last injection of XIAFLEX) and that subsequently increases by at least 20 degrees compared to the reference value with a palpable cord present or, (b) a joint which underwent medical or surgical correction to treat contracture in that joint.  

About Surgical Recurrence in Dupuytren's contractureThe surgical literature has variable definitions as to what constitutes recurrence.  Depending upon the publication, the type of surgery performed (fasciectomy, fasciotomy, or needle aponeurotomy) and the definition of recurrence, surgical recurrence rates of up to 34% have been reported within the first two years following fasciectomy(6) and, at two years, rates range from 2% to 60% or more (7).  Three year surgical recurrence rates can vary from 10% to 65%(2,3,4,8-15), depending upon definition of recurrence.  When using a recurrence definition of 30 degrees of worsening, the recurrence rate for fasciectomy was 24% with a mean time to recurrence of 3.7 years(4) and needle aponeurotomy demonstrated a recurrence rate of 65% at 32 months(3,4).  When using a recurrence definition of re-operative rate, fasciectomy was 10-15% at approximately 3 years(10,14) and needle aponeurotomy was 19-42% at approximately 3 years(2,3,15,16,17).  Higher recurrence rates are seen with surgery in Proximal Intra-Phalangeal (PIP) joints vs. Metacarpal Phalangeal (MP) joints(7) and with needle aponeurotomy vs. fasciectomy(2,3).  Generally, the higher the initial stage of contracture before surgery, the more severe the recurrences(18).  The earliest reports of recurrence for fasciectomy were seen in 22% of female and 19% of male
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SOURCE Auxilium Pharmaceuticals, Inc.
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Related medicine technology :

1. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
2. Auxilium Pharmaceuticals, Inc. Announces XIAFLEX(TM) Meets Primary Endpoint With Statistical Significance (p<0.001) in CORD I Pivotal Phase III Study for Dupuytrens Contracture
3. BioSpecifics Technologies Corp. Announces Auxilium XIAFLEX® Update
4. Auxilium Pharmaceuticals, Inc. Announces Initiation of XIAFLEX® Phase III Studies for Peyronies Disease
5. Auxilium Pharmaceuticals, Inc. Announces Issuance of Patent for Clostridial Collagenase
6. Auxilium Pharmaceuticals to Present at the 2010 Annual Credit Suisse Healthcare Conference
7. Auxilium Pharmaceuticals Reports Preliminary Fourth Quarter 2010 Net Revenue and Announces 2011 XIAFLEX Revenue Guidance
8. Auxilium Pharmaceuticals to Present at the 2011 Citi Annual Global Healthcare Conference
9. Auxilium Pharmaceuticals to Present at the Cowen and Company 31st Annual Health Care Conference
10. Auxilium Pharmaceuticals, Inc. Completes Enrollment of XIAFLEX® Phase III Double-Blind Studies for Peyronies Disease
11. Auxilium Pharmaceuticals, Inc. and Asahi Kasei Pharma Corporation Enter Agreement to Develop, Commercialize and Supply XIAFLEX® In Japan
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