Xiaflex: Phase IIa data
Top-line data from an open-label, U.S. Phase IIa trial in 50 adults with stage 2 unilateral idiopathic frozen shoulder syndrome showed that 0.58 mg Xiaflex in 1 and 2 mL injection volumes given every 3 weeks for up to 3 injections plus shoulder exercises each met the primary endpoint of improving active forward flexion in the affected shoulder from baseline to day 92 vs. exercises alone (p<0.05 for both). Additionally, 0.58 mg (1 mL) Xiaflex plus exercise significantly improved shoulder abduction from baseline to day 92 vs. exercise alone (p<0.05), but the 0.58 mg (2 mL) dose was not significant on the endpoint. Both 0.58 mg (1 mL) and 0.58 mg (2 mL) doses of Xiaflex plus exercise also significantly improved American Shoulder and Elbow Surgeons (ASES) scale pain and function scores from baseline to day 92 vs. exercise alone (p<0.05 for both).
Neither dose of Xiaflex plus exercise significantly improved external or internal rotation from baseline vs. exercise alone, and the 0.29 mg (1 mL) and 0.58 mg (0.5 mL) doses of Xiaflex plus exercise did not lead to significant improvements on any endpoint. The most common treatment-related adverse events reported were localized bruising, injection-site pain and swelling, hematoma and musculoskeletal pain. Day 92 MRI evaluations indicated that there were no rotator cuff injuries and no treatment-related serious adverse events were reported. Auxilium plans to start a placebo-controlled Phase II trial of Xiaflex in frozen shoulder syndrome next half. ...