Auxillium’s "Positive" Data For Xiaflex Not So Positive Given Severe Side Effects

Auxilium Pharmaceuticals (NASDAQ:AUXL) announced top-line data from a Phase IIIb trial evaluating treatment with Xiaflex for multiple Dupuytren’s Contracture cords at one time. The company called the data “positive”, as the 60-patient trial demonstrated response rates of 76% at the knuckle joint in the hand (MCP joint — 60% of all joints requiring treatment), but just 33% at the finger joint above (the PIP joint – next most common joint). The company plans to begin a larger trial for the treatment of multiple cords in the third quarter. Importantly, adverse events, including bruising, pain, itching, and lymphadenopathy were higher than observed in previous trials, which could make the FDA more cautious in approving the treatment for multiple cords at one time. Also adding to the safety concern (more…)