A DSMB provides an independent evaluation of all trial data against potential security issues could identify justify the modification or early termination of ongoing studies. The FAME DSMB, a group of four ophthalmologists and a biostatistician met, the the Medidur FA Phase III clinical trial data.
Remains a significant financial interest in IluvienTM and other products under this agreement without any obligation to finance the development to finance the development of the products ‘.. FAME are two, duplicate, double-masked, randomized, multicenter studies to 956 patients in the U.S., in October 2007. India evaluated for 36 months in support of a planned global registration application with the safety and efficacy after two years of follow-up. Registration for the FAME study was completed in October 2007.Primary endpoint of in randomized double-blind pivotal efficacy trial Auxilium mead announced today positive results randomized, placebo-controlled double-blind study of AA4500 in treatment of Dupuytren’s disease, known as Dupuytren’s contracture. BioSpecifics Technologies Corp., licensers on AA4500, sponsored and monitored the studies , and Auxilium conducted follow-up and data Analyses.
AA4500 reached a 91 percent success rate the primary endpoint below five degree contraction observed in treated joints, both Proximal Intranational-phalangeal and the PIP, joint and the metacarpal phalangeal or MP joint of for up to three injections.
, placebo-controlled Pharmaceuticals Announces Top line Results The of a pivotal efficacy trial out of AA4500 Add Dupuytren’s disease.. Auxilium Pharmaceuticals, today announced top-line Results The made of a pivotal to the to the AA4500, his injectable enzyme product, to patient with Dupuytren’s disease.