FDAnews
www.fdanews.com/articles/102320-auxilium-completes-enrollment-in-two-xiaflex-trials

Auxilium Completes Enrollment in Two Xiaflex Trials

December 17, 2007

Auxilium Pharmaceuticals has enrolled all patients in its U.S. and Australian Phase III studies of Xiaflex for the treatment of Dupuytren’s contracture, a condition involving the thickening and shortening of the normal ligaments of the palm and fingers.

All patients have received their first injection of Xiaflex (clostridial collagenase for injection) or placebo, and more than 300 patients have enrolled in the studies.

In the U.S. CORD I study, patients must have at least 20 degrees of contracture. The primary endpoint is to determine whether Xiaflex can reduce contracture angle of the primary joint to within zero to five degrees of normal.

The Australian CORD II study follows a protocol similar to the CORD I study.

Armando Anido, Auxilium’s president and CEO, said the company intends to file a biologics license application with the FDA in early 2009.