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Study Finds Botox Alternative Better at Smoothing 'Crow's Feet'
Date:6/20/2011

ld personally say about that," noted Maas, "is that if you already own 90 percent of the market why would you fund a study where if you tied you lost? But I will add that Allergan didn't like the dosing or the statistical analysis we used, despite the fact that I believe the body of scientific evidence supports the way we handled both."

But Allergan issued a statement Monday that challenged the findings on several grounds, which included the small size of the study, the short length of the trial and, most importantly, the dosing ratio the researchers used when deciding how much of each product to use on the patients' faces.

"It is important to understand that no two botulinum toxins are alike and each has a unique molecular structure, formulation, potency and safety profile," the company said in its statement. "In fact, the U.S. FDA-required product labels for BOTOX Cosmetic and other botulinum toxins state that different botulinum toxin products are not interchangeable and no consistent dose ratio exists among botulinum toxin products."

"The most significant flaws in this study's design were the attempted dose conversion and injection pattern. In this study, patients were treated with 10 units of BOTOX Cosmetic and 30 units of Dysport. As stated above, BOTOX Cosmetic and Dysport are not interchangeable and there is no established dose conversion, meaning 10 units of BOTOX Cosmetic does not equal 30 units of Dysport. When patients are treated with BOTOX Cosmetic for its approved indication in the glabellar (vertical frown lines between the eyebrows), they typically receive 20 units, which is the FDA-approved dose. In addition to specific dosing regimens, BOTOX Cosmetic also has a unique injection pattern for proper administration, pending the treatment area and individual patient."

Dr. Doris Day, a dermatologist with Lenox Hill Hospital in New York City, also cautioned that the attempt to analytically stack two "very similar" drugs agai
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