The cheers of women were heard far and wide yesterday when Auxilium Pharmaceuticals said its experimental cellulite drug demonstrated a “statistically significant improvement” in patients’ scores on the appearance scale used in a study required by the Food and Drug Administration (FDA). The biopharmaceutical company added 68 percent of the patients in the mid and high dose groups reported being "satisfied" or "very satisfied" with the results of Xiaflex, or collagenase clostridium histolyticum (CCH), compared to only 34 percent of patients in the placebo group. Currently, there are no FDA-approved treatments for cellulite. "We look forward to initiating a planned Phase 2b clinical trial in the second quarter of 2015," said Adrian Adams, Chief Executive Officer and President of Auxilium Pharmaceuticals.
Cellulite, or edematous fibrosclerotic panniculopathy as it is referred to by scientists, affects women of all races and ethnicities and has been reported in 85 to 98 percent of post-pubertal females. The characteristic lumpy, dimpling of the skin involves a loss of elasticity or shrinking of collagen cords, called "septae," that attach the skin to the muscle layers. When fat expands, the septae tether the skin, and dimples appear. Xiaflex is intended to target and break those tethers with the goal of smoothing of the skin — getting rid of the cellulite.
To test Xiaflex, the company enrolled 150 American women between the ages of 18 and 45. Each woman received up to three treatment sessions of either the experimental drug or placebo. Up to 12 shots were injected directly into each woman’s cellulite, across an entire treatment quadrant — left or right buttock or left or right posterior thigh. All of the women tolerated CCH well, with most of the reported side effects being mild to moderate and limited to the local injection area. A full 86 percent of all side effects resolved within 21 days.
Only one woman experienced a serious side effect during the trial, and this was, according to the company, unrelated to the drug.
Xiaflex is a biologic — a medicine manufactured from biological sources — that has already gained FDA approval in the U.S. along with regulatory approval in the EU, Canada, and Australia for the treatment of adult Dupuytren's contracture, a progressive hand disease that prevents a patient from straightening and properly using their fingers. The FDA has approved the drug to treat men with curvature of the penis, a condition known as Peyronie's disease, as well.