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Topaz Pharmaceuticals Announces Positive Data from Topical Ivermectin Trials Presented at Society of Pediatric Dermatology

Wed, 07/28/2010 - 5:39am
Bio-Medicine.Org

HORSHAM, Pa., July 28 /PRNewswire/ -- Topaz Pharmaceuticals Inc., a privately held biotechnology company, announced positive results of studies of topical ivermectin cream, which it is developing as a potential  treatment of Pediculus humanus capitis (head lice).  

In a Phase 2 dose-ranging study presented at the annual meeting of the Society for Pediatric Dermatology in Portland, OR, this novel topical formulation produced a statistically significant eradication of live lice as compared to vehicle.  The results from another study presented at the meeting indicated that there was minimal plasma absorption of ivermectin when the topical formulation was applied to children as young as six months.

"Our foremost goal at Topaz is the successful development of topical ivermectin as a convenient application for the treatment of head lice infestations," said Thomas Beck, MD, Chief Medical Officer of Topaz Pharmaceuticals. "These results further support our belief that our topical ivermectin formulation has the potential to become an important treatment option. We anticipate concluding Phase 3 trials imminently and then to quickly progress to file a new drug application with the U.S. Food and Drug Administration."

Terri Meinking, PhD, President of Global Health Associates of Miami, Inc., presented a poster describing a dose determination study to establish the optimum concentration of ivermectin. The poster described a randomized, double-blind, dose-response study of 74 evaluable patients who received treatment with 0.15%, 0.25%, or 0.5% ivermectin, or vehicle.  All ivermectin concentrations (n=51) produced a statistically significant erad

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