[Refiles story posted Jul 30, 2012 to correct coding issues; no changes to headline or text.]
(Reuters) – Auxilium Pharmaceuticals Inc today announced positive top-line data from its open-label phase IIIb trial evaluating Xiaflex (collagenase clostridium histolyticum) for the treatment of adult Dupuytren’s contracture patients with multiple palpable cords.
The drug is already marketed as a treatment for Dupuytren’s contracture, which results in the appearance of rope-like cords between the palm and fingers that prevent sufferers from straightening their fingers.
Auxilium is conducting studies to seek a multicord indication for Xiaflex from the U.S. Food and Drug Administration. The drug is currently recommended to be used in one cord at a time.
The company said patients with multiple cords who received concurrent injections of 0.58 mg of Xiaflex experienced numerically higher response rates than those who received the first single injection in the late study that supported the current marketing approval.
“We are very pleased to announce this important new data exploring the utility of treating patients with multiple palpable cords and expect to begin a larger trial soon that, if successful, may allow us to seek expansion of the current Dupuytren’s indication for Xiaflex,” Auxilium Chief Executive Adrian Adams said in a statement.
“Physicians who treat Dupuytren’s and their prospective patients would be receptive to the potential ability to treat more affected joints at a single treatment session using a non-surgical treatment alternative,” Adams said.
There were two related serious adverse events reported in the phase IIIb trial: an A2-A4 pulley rupture/ligament injury of the middle finger after middle and ring finger metacarpophalangeal joint injections and a 24-hour hospitalization for pain control after two injections into a little finger.
The company says it does not believe the rate of tendon/ligament injury following two concurrent injections is any different clinically from the overall experience with Xiaflex to date and intends to continue to monitor for these events very closely.
In the completed clinical study program, four of 1,082 subjects in the program experienced a tendon rupture/ligament injury for a rate of 0.4%, the company said.
To date, approximately 20,000 patients have received commercial Xiaflex injections in the United States with a reported overall tendon rupture/ligament injury rate of approximately 0.1%.
Auxilium expects to begin a larger study with Xiaflex for the concurrent treatment of multiple palpable cords in the third quarter of 2012.