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.