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
HSBC is reportedly laying off about 100 of its senior investment bankers worldwide, as the banking giant strives to curb operating costs. According to reports, the London-headquartered bank will eliminate managing director and director level employees at the Global Banking and Markets division, as... Samsung Electronics Co., Ltd. (SMSN.L, SSNNF.OB, SSNLF.OB) will reportedly blame faulty batteries for last year's Galaxy Note 7 fiasco. According to a Wall Street Journal report, Samsung's investigation of Galaxy Note 7 smartphones found that some batteries were irregularly sized while others had... Federal investigators have closed their probe of a fatal crash that involved a Tesla Motors Inc. car eight months ago. The regulators said they have found no safety defects in the vehicle's automated driving system and that Tesla's Autopilot-enabled vehicles did not need to be recalled.
comments powered by Disqus
Follow RTT