Auxilium Pharmaceuticals (AUXL) Drug Found Effective Against Cellulite In Phase 2 Study
8/21/2014 6:13:44 AM
Auxilium Pharmaceuticals Drug Found Effective Against Cellulite In Phase 2 Study
August 21, 2014
By Krystle Vermes, BioSpace.com Breaking News Staff
Auxilium Pharmaceuticals (AUXL) , a Pennsylvania-based biopharmaceutical company, announced positive results today in a randomized, double-blind Phase 2a study of collagenase clostridium histolyticum. CCH was being used for the treatment of edematous fibrosclerotic panniculopathy, commonly known as cellulite, in the study.
During the Phase 2a study, there were three different doses of CCH administered to participants ranging from 0.06mg to 0.84mg. When given any dose of CCH, individuals showed a reduction in the appearance of cellulite. In the mid-to-high dose range, 68 percent of patients were “satisfied” or “very satisfied” with the results.
"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 study looked at 150 women between the ages of 18 and 45 from the U.S. Each individual received three treatments of either the drug or the placebo, and the treatments were 21 days apart.
"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."
Cellulite can be defined as a localized metabolic disorder of tissue under the skin. It affects women of all ethnicities and has been reported in up to 98 percent of women. Cellulite can result in the loss of elasticity or shrinking of collagen cords.
Auxilium Pharmaceuticals has a product portfolio that focuses on orthopedics, dermatology and other therapeutic areas. The company is dedicated to commercializing products geared toward specialist audiences. Auxilium Pharmaceuticals is also a leader in products for men’s healthcare. Currently, the company has a portfolio of 12 approved products that span across its areas of focus.
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