Companies have been trying to come up with a new treatment for cellulite and
recently, Auxilium Pharmaceuticals announced their efforts have been positive.
Cellulite is a localized metabolic disorder of tissue under the skin that has been reported in 85 to 98 percent of post-pubertal females.
The condition involves the loss of skin elasticity due to the shrinking of collagen cords that attach skin to muscle. When the fat in cellulite prone areas expands, the cords tether the skin, causing surface dimpling characteristic of cellulite.
Auxilium Pharmaceuticals announced a progress in efforts of trying to develop a new treatment for cellulite.
They company said two doses of its drug to smoothen cellulite were statistically significant in a mid-stage study.
“We continue to be encouraged by the promising and positive results of our CCH program, specifically these Phase 2a data in the cellulite indication,” said Adrian Adams, Chief Executive Officer and President of Auxilium Pharmaceuticals. “We believe these data establish proof-of-concept for CCH as a potential treatment for cellulite and enable Auxilium to pursue our development and regulatory strategy to most efficiently and effectively advance this exciting program. We look forward to initiating a planned Phase 2b clinical trial in the second quarter of 2015.”
The Phase 2a study included 150 women between the ages of 18 and 45 in the United States. Each woman received three treatment sessions of either the CCH drug or a placebo and each treatment session was approximately 21 days apart. Up to 12 injections were administered into cellulite dimples during each session across an entire treatment quadrant – left or right buttock or left or right posterior thigh. Only the dimples treated on Day 1 were able to be retreated on Day 22 (Treatment Session 2) and Day 43 (Treatment Session 3) if, in the opinion of the investigator, the dimple continued to be evident. A variable number of dimples were able to be treated within one treatment quadrant.
Auxilium said 68 percent of the women given a mid and high dose of CCH, already marketed as Xiaflex to treat other conditions, reported being “satisfied” or “very satisfied” with the results, compared to only 34 percent of them given a placebo.
“These data have exceeded our expectations, demonstrating statistically significant improvements in cellulite as measured by both physicians and patients,” said James Tursi, Chief Medical Officer of Auxilium Pharmaceuticals. “These are challenging endpoints and ones that we believe are critical in the context of regulatory consideration. We are continuing to analyze these exciting data and will be gathering key opinion leader and regulatory input and look forward to publishing and presenting our findings in peer-reviewed venues in the future.”
Xiaflex is already approved for Dupuytren’s contracture with palpable cord and Peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. Currently Xiaflex is in Phase 2 development for cellulite and Frozen Shoulder Syndrome.