Dosing commences in Auxilium's XIAFLEX phase IIIb trial for Dupuytren's contracture

Oct 3 2011

Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced that the first patients have been dosed in the Company's phase IIIb trial of XIAFLEX^® for the treatment of adult Dupuytren's contracture patients with multiple palpable cords.  The study is expected to enroll approximately 60 patients at eight sites throughout the U.S. and Australia and patients will be monitored for 60 days following their last injection.  It is estimated by SDI Health, LLC that up to 40% of annual Dupuytren's surgeries are performed to treat two or more cords concurrently. 

"We are extremely pleased to initiate this important post-approval study as we believe the results could provide those physicians that treat Dupuytren's additional important safety information about treating multiple joints in the same hand concurrently," said Dr. James Tursi, Chief Medical Officer of Auxilium.  "We anticipate having the results of this trial in the second half of 2012."

The phase IIIb study is an open-label study that is designed to assess the safety and efficacy of concurrent administration of two injections of XIAFLEX into the same hand of subjects with at least two Dupuytren's contractures caused by palpable cords.  Safety assessments, including immunogenicity testing, will be made during all study visits.  Efficacy assessments will include measuring finger goniometry and range of motion of the treated joints on days 1, 8, 30, and 60, following the first cycle of two injections. Upon completion of the day 60 follow-up visit following the first treatment cycle, subjects who require additional treatment in the treated hand may receive XIAFLEX in other individual cords, up to a total of five total injections.