Topaz Pharmaceuticals announced the completion of two Phase 3 clinical trials that studied the use of ivermectin topical cream as a potential treatment for head lice. These trials were conducted according to a Special Protocol Assessment (SPA) agreement with the Food and Drug Administration (FDA). These studies compared 0.5% ivermectin cream with a vehicle control (placebo). Either ivermectin topical cream or placebo was dispensed to clinical trial participants 6 months of age and older for application to dry hair and scalp. The primary efficacy endpoint for these studies was achieving “lice free” status within approximately 24 hours of application and maintaining this status for at least 14 days after application. Patients were also evaluated for safety and local tolerability. Topaz plans to submit its new drug application (NDA) to the FDA in 2011.
Ivermectin is a broad-spectrum antiparasitic agent. Its antiparasitic mechanism of action is through binding 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. Widespread oral use of ivermectin, under the brand name Mectizan, began in 1987 in sub-Saharan Africa to control onchocerciasis (river blindness) in humans.
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