These results are based on a multicenter, 12-month, open-label Phase IIIb study conducted at 21 sites across the United States, evaluating 165 adults who received injections of ATX-101 for up to six treatments at four-week intervals. Patients received ATX-101 (2 mg/cm 2) by subcutaneous microinjections directly into their SMF, and were evaluated three months after their last treatment. The study population includes females (77.6 percent) and males (22.4 percent) with a mean age of 47, who report at least moderate SMF and dissatisfaction with the appearance of their chin. All Fitzpatrick Skin Types, an industry standard scale to categorize skin tone, are represented.“We are pleased with these ATX-101 study results,” said Patricia S. Walker, M.D., Ph.D., chief medical officer, KYTHERA Biopharmaceuticals, Inc. “These results, along with efficacy analyses in double-blind, placebo-controlled studies, support ATX-101 entering the market as potentially the first medical aesthetic drug approved for the reduction of submental fat.”
KYTHERA Biopharmaceuticals, Inc. Announces Positive Interim Results From Open-Label Study Of ATX-101 In The Reduction Of Unwanted Submental Fat (SMF) Or “Double Chin”
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