Xiaflex meets in Phase IIa cellulite trial
Auxilium Pharmaceuticals Inc. (NASDAQ:AUXL) said 0.48 and 0.84 mg doses of Xiaflex collagenase clostridium histolyticum each met the primary endpoint in a Phase IIa trial to treat cellulite. The primary endpoint of the 150-patient, U.S. study was assessment of the change from baseline to day 73 in the appearance of cellulite vs. placebo (p<0.05 for both). A 0.06 mg dose missed the endpoint. Patients received up to three treatment sessions of up to 12 injections in cellulite dimples. In 2Q15, Auxilium plans to start a Phase IIb trial in the indication.
The injectable form of collagenase is approved in the U.S. as Xiaflex and as Xiapex in the EU to treat Dupuytren's contracture in adult patients with a palpable cord, which affects joints in the hand. In the U.S., Xiaflex is also approved to treat Peyronie's disease. ...