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

NewsGuard 100/100 Score

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.


Auxilium Pharmaceuticals, Inc.


The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
Olive oil's secret weapon against Alzheimer's: phenolic compounds