AUXILIUM REPORTS FINDINGS ON DRUG FOR CONTRACTURE

Auxilium Pharmaceuticals has announced positive final results from a Phase III study of its lead product AA4500 in the treatment of Dupuytren's contracture, a disabling and recurring condition in which the joints in the hand contract.

The study consisted of a randomized, placebo-controlled, double-blind phase, as well as an open-label phase. Data from the double-blind phase showed that injecting the collagenase enzyme into study patients' affected joints led to a 91 percent success rate in reducing joint contracture to within five degrees of normal, compared with the placebo arm in which no patients achieved success. In the open-label phase, in which patients had additional joints treated with AA4500, results showed that 88 percent of metacarpophalangeal joints and 68 percent of proximal interphalangeal joints were fully corrected.

"These statistically significant study results exceeded our expectations and show the potential for AA4500 to become an effective, first-line therapy for patients suffering from Dupuytren's contracture, a condition currently treated with complex hand surgery," Lawrence Hurst, the study's principal investigator, said. "AA4500 was well tolerated. It was reassuring that we were able to give patients multiple injections in multiple joints with no immunological side effects."

Safety data in both studies showed that the most commonly reported adverse events were pain and swelling (edema) of the hand at the injection site, and postinjection temporary swelling of a modest nature in the lymph node area of the armpit. Adverse events were mild to moderate in nature and resolved without treatment within 30 days.

Auxilium is also studying AA4500 as a treatment for Peyronie's disease and frozen shoulder syndrome.