Xiaflex: Phase IIa data
Top-line data from a double-blind, U.S. Phase IIa trial in 150 women ages 18-45 with cellulite showed that the 0.48 and 0.84 mg doses of Xiaflex each met the co-primary endpoints of improving investigator-assessed GAIS score (post hoc analysis, mid- and high-dose Xiaflex also significantly improved the composite of investigator- and patient-assessed GAIS scores vs. placebo (p=0.021 and p=0.004, respectively). Patients received Xiaflex or placebo given in up to 3 treatment sessions of up to 12 injections each administered into cellulite dimples. Each session was about 21 days apart. Auxilium plans to start a Phase IIb trial of Xiaflex to treat cellulite in 2Q15.
Xiaflex is approved in the U.S., Canada, Australia and the EU, where it is known as Xiapex, to treat Dupuytren’s contracture in adult patients with a palpable cord, which affects joints in the hand. The product is also approved in the U.S. to treat Peyronie’s disease in adult men who have a plaque that can be felt and a curve in their penis >=30 degrees. The product is under review in the U.S. to treat 2 Dupuytren’s contracture cords concurrently, with an Oct. 20 PDUFA date. Xiaflex has Orphan Drug status in the U.S. for Peyronie’s disease and Dupuytren’s contracture. ...