Auxilium touts top-line data from Xiaflex study in Dupuytren's contracture

Monday, July 30, 2012 11:34 AM

Auxilium Pharmaceuticals, a specialty biopharmaceutical company based in Malvern, Penn., issued positive top-line data from its phase IIIb trial evaluating Xiaflex for the treatment of adult Dupuytren's contracture patients with multiple palpable cords. 

This open-label study enrolled 60 patients at eight sites throughout the U.S. and Australia. Patients received two concurrent injections of 0.58mg of Xiaflex per affected hand and efficacy was based on a single injection per contracted joint. At 30 days, 60% of all joints, 76% of metacarpophalangeal (MP) and 33% proximal interphalangeal joints achieved clinical success (defined as joint correction to 0 to 5 degrees). These response rates are numerically higher than the response rates seen after the first single injection in the double-blind placebo controlled phase III studies.

The most common adverse events reported in the phase IIIb trial were bruising, pain and swelling at the treatment site and were comparable to the previous trials and resolved within 14 days. 

Auxilium expects to begin a larger study with Xiaflex in the third quarter of 2012 for the concurrent treatment of multiple palpable cords that, if successful, may allow the company to seek FDA approval and expansion of the Dupuytren's label.  

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

September 15

WIRB-Copernicus Group acquires New England IRB

BBK Worldwide secures $3 million in private á¼€nancingto accelerate its global and technological expansion

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

Already a subscriber?
Log in to your digital subscription.

Purchase the August issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

July

IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

Already a subscriber?
Log in to your digital subscription.

Purchase the July issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs