Clinical Trial Of Auxilium’s Xiaflex Shows It To Be Effective In Smoothing Cellulite
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Almost everyone is aware what cellulite is, where once smooth skin was, now are ripples. It happens to both men and women as they put on weight and age. Because it’s thought to be unsightly, many researchers have been searching for ways to reduce and eradicate this completely. Till today, in spite of the large and ever growing cosmetics market in the world and the wide range of products available to the patients, none exists that could actually fix the problem.
That is about to change soon as the drug that is being tested by Auxilium claims to smooth the skin of those with cellulite. A mid-stage concluded that only two doses of already approved Xiaflex (collagenase clostridium histolyticum, or CCH) by Auxilium Pharmaceuticals (AUXL) can improve the appearance of cellulite. The company, on Thursday claims to have achieved a breakthrough in the field of cellulite reduction.
The stocks are reported to have jumped by 7% in early trading, though AUXL is still down 50% from the highs it reached in early March. The company is now showing an indication that Xiaflex could be a welcome addition despite having posted a larger-than-expected loss in the second quarter.
Auxilium Pharmaceuticals has reported that two of their three tested doses of CCH “ 0.48mg and 0.84mg have produced a statistically substantial reduction in the appearance of cellulite. It had been measured by investigator and patient and the scoring was done on the Global Aesthetic Improvement Scale (GAIS). In a double blind study, out of all the
patients, 68% reported being Satisfied or Very Satisfied with the results so far as compared to 34% of the patients receiving placebo.
The improvement in the reduction of cellulite was also statistically concrete when measured by investigators. CCH was well-tolerated among all the patients with only mild to moderate adverse events.
In total 150 women, aged 18 and 45 were enrolled for the phase 2a of the study in the United States. Each patient was given up to three treatment sessions, which were 3 weeks apart, with upto 12 injections during each session.
Xiaflex has been approved for Dupuytren's contracture and Peyronie's disease at 0.58 mg and has so far generated $26.3 million in revenue in the second quarter. Auxilium is also in talks of merging with QLT Inc (QLTI). This way Auxilium can take advantage of the Canadian company's lower corporate tax rate.
Having concluded the study, the biopharmaceutical company, Auxilium announced that the results of clinical trials of study Phase 2a of Xiaflex are promising to the core and have shown
great improvements in all the women and have resulted in smooth skin for every patient in the trials.
Xiaflex is believed to be exceptionally safe, with exception to a few adverse events, when it comes to reducing cellulite among men or women of all age groups. It works, as the company reports;
It breaks down the collagen tethers that connect the skin to the muscle underneath. When these collagen cords are let loose, their elasticity increases thus reducing the dimpling. Dimpling occurs when fat builds up the tethers beneath the skin and it can’t expand as the skin is pushed outwards, which causes ripples to occur.
Xiaflex medication allows these cords to stretch to some extent, thus reducing dimpling. In the clinical trial, 150 women with cellulite were given three rounds of Xiaflex shots or a placebo in a body part where the cellulite was maximum. Almost all of the patients at the clinical trials reported satisfaction, which was calculated using the Global Aesthetic Improvement Scale in accordance with the amount of medication administered.
Auxilium ‘s stock price sky rocketed after the announcement, and billions are likely to be earned by the millions who will use this drug. The drug next has to undergo a Phase 2b clinical trial, by the start of next year where it will go through safety checks and other standard checks.
References
https://sciencex.com/authors/bobyirka/