Auxilium Pharma (AUXL) Updates on XIAFLEX; Says No Meaningful Safety Profile Change Observed
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Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL), announced a safety update following 30 months of post-approval use in the U.S. of XIAFLEX for the treatment of adult Dupuytren's contracture patients with a palpable cord. After approximately 27,000 injections administered to approximately 21,000 patients in the U.S., there was no clinically meaningful change in the nature of events expected relative to the clinical trial safety profile.
From February 2, 2010 through July 31, 2012, approximately 1,454 adverse events have been reported to the Company. Of those reported events, the most commonly reported events were laceration, peripheral edema (swelling) and contusion (bruising). Adverse event reporting requirements post-approval are different from requirements for reporting such events during a clinical trial. See "About Voluntary Safety Reporting" below.
In the phase III clinical trials for registration, three (0.3%) subjects experienced a tendon rupture and one (0.1%) subject experienced ligament damage (pulley rupture) following XIAFLEX treatment of 1,082 subjects in the safety database. In the U.S. post-marketing period, 19 tendon ruptures (0.09%) and 3 ligament injuries (0.01%) from approximately 21,000 patients treated with commercial drug were reported. Additionally, there has been a single report of complex regional pain syndrome (0.005%), that resolved within approximately 3 months, and a single case of residual stretch neuropraxia (numbness without pain) (0.005%) with full finger extension and remote from the injection site. Since launch, nearly 2,000 U.S. physicians have injected palpable cords in Dupuytren's contracture patients with XIAFLEX.
From February 2, 2010 through July 31, 2012, approximately 1,454 adverse events have been reported to the Company. Of those reported events, the most commonly reported events were laceration, peripheral edema (swelling) and contusion (bruising). Adverse event reporting requirements post-approval are different from requirements for reporting such events during a clinical trial. See "About Voluntary Safety Reporting" below.
In the phase III clinical trials for registration, three (0.3%) subjects experienced a tendon rupture and one (0.1%) subject experienced ligament damage (pulley rupture) following XIAFLEX treatment of 1,082 subjects in the safety database. In the U.S. post-marketing period, 19 tendon ruptures (0.09%) and 3 ligament injuries (0.01%) from approximately 21,000 patients treated with commercial drug were reported. Additionally, there has been a single report of complex regional pain syndrome (0.005%), that resolved within approximately 3 months, and a single case of residual stretch neuropraxia (numbness without pain) (0.005%) with full finger extension and remote from the injection site. Since launch, nearly 2,000 U.S. physicians have injected palpable cords in Dupuytren's contracture patients with XIAFLEX.
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