logo
Share SHARE
FONT-SIZE Plus   Neg

Auxilium Pharma Reports Positive Top-line Data From XIAFLEX Phase IIIb Trial

Auxilium Pharmaceuticals Inc. (AUXL) reported positive top-line data from its open-label phase IIIb study, assessing XIAFLEX for the treatment of adult Dupuytren's contracture patients with multiple palpable cords. The company enrolled 60 patients at 8 sites throughout the U.S. and Australia. During the third quarter of 2012, Auxilium expects to begin a larger study with XIAFLEX for the concurrent treatment of multiple palpable cords that, if successful, may allow the company to seek Food and Drug Administration approval and expansion of the Dupuytren's label.

Based on research by SDI Health, LLC estimating that 35% - 40% of annual Dupuytren's surgeries in the U.S. are performed to treat two or more cords concurrently, Auxilium is conducting these trials to seek a multicord indication for XIAFLEX from the FDA.

In this phase IIIb multicord trial, 60 patients received two concurrent injections of 0.58 mg of XIAFLEX per affected hand and efficacy was based on a single injection per contracted joint.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Taco Bell, a division of Yum! Brands Inc, is planning to test delivery of food items on college campuses, the Street reported. The move comes at a time the fast food chain seeks to leverage demand for its popular breakfast and dinner items. In an unusual incident, an Airbus operated by Singapore Airlines temporarily lost power on both its Rolls Royce engines during a flight and plunged almost 13,000 feet or 3.96 kilometers. However, pilots managed to save the Airbus through standard operational procedures and it continued on its routine path. Hormel Foods has agreed to buy organic meat products maker Applegate Farms LLC for about $775 million, as consumers increasingly use natural and organic foods in their diet.
comments powered by Disqus
Follow RTT