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Topaz Pharmaceuticals' Ivermectin Cream In Vitro Data Demonstrates Activity Against Head Lice Eggs

HORSHAM, Pa., July 11, 2011 /PRNewswire/ -- In a study sponsored by Topaz Pharmaceuticals Inc., a privately held specialty pharmaceutical company, scientists from the University of Massachusetts, Amherst presented data showing that a 0.5% ivermectin (IVM) cream formulation was active against lice eggs from permethrin resistant head lice.  The data were presented in a poster presentation on Saturday, July 9, 2011 at the 37th Annual Meeting of the Society for Pediatric Dermatology in Baltimore, Maryland.  

"These data build on our earlier work showing this ivermectin formulation is active against head lice," said John M. Clark, Ph.D., Professor of Veterinary and Animal Sciences, University of Massachusetts Amherst.  "The data suggest that a single treatment with 0.5% ivermectin cream has the potential to fully break the head louse life cycle.   If approved by the FDA, ivermectin cream has the potential to provide physicians with an attractive treatment option."  

In the study, permethrin resistant head lice were allowed to lay eggs in tufts of human hair.  Adult lice were removed and the tufts with eggs were exposed to 0.5% ivermectin cream, to vehicle only, or to unformulated, diluted ivermectin. After a 10-minute exposure, tufts were thoroughly rinsed and incubated.  Any hatched lice were placed onto new tufts and moved to a feeding cup.  The hatchability of treated eggs was not affected by ivermectin. No differences were detected between the mortality rate of eggs exposed to 0.5% ivermectin cream and those exposed to unformulated ivermectin.  The percent of hatched lice from eggs exposed to 0.5% ivermectin cream that took a blood meal, relative to eggs exposed to placebo, was significantly decreased (by 82-95%).  All hatched lice from eggs treated with 0.5% ivermectin cream died within 48 hours.  

About Ivermectin

Ivermectin is a broad-spectrum antiparasitic agent.  Its known mechanism of action is that it binds selectively to certain ion channels present in invertebrate nerve and muscle cells but not present in mammals. The resulting increase in permeability of the cell membrane causes the death of certain parasites.  First developed from a soil bacterium, widespread oral use of ivermectin, under the brand name Mectizan®, began in 1987 in sub-Saharan Africa to control river blindness (onchocerciasis) in humans.  More than one billion treatments of oral ivermectin have been administered to help alleviate the suffering caused by river blindness and lymphatic filariasis.  On June 7, 2011, FDA accepted the new drug application of Topaz Pharmaceuticals for the use of a novel topical form of ivermectin as a potential therapy to treat head lice.  This submission is presently under review by FDA.

About Topaz Pharmaceuticals

Topaz Pharmaceuticals Inc. is a privately held specialty pharmaceutical company focused on developing and commercializing treatments primarily for the pediatric and dermatology markets. The company's lead investigational product is a topical cream formulation of ivermectin currently under development for the treatment of head lice infestations in children and adults which affect between six and 12 million people every year. Topaz has completed two phase 3 studies of ivermectin and has filed its new drug application for this potential indication. Topaz, headquartered in Horsham, PA, is backed by top-tier investors including Aisling Capital and Fidelity Biosciences.  For more information about Topaz Pharmaceuticals Inc., please visit

Contact Information
E. Blair Schoeb
Tel: 908-277-0386

SOURCE Topaz Pharmaceuticals Inc.
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