Topaz Pharmaceuticals Announces Completion of Pivotal Phase III Trials of Ivermectin Topical Cream

Topaz Pharmaceuticals Inc., recently announced the completion of two Phase III 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 FDA. "Parents and caregivers are looking for safe and effective treatments for head lice," said Thomas Beck, MD, Chief Medical Officer at Topaz, in a press release. "Current treatment options are limited by safety, efficacy and convenience issues. We believe there is an unmet need to provide a new option for the more than 6 million people, mostly school aged children who are impacted by lice each year in the US. The completion of our two Phase III clinical trials is a critical milestone in our development of ivermectin topical cream as a potential head lice treatment and for Topaz, as we continue to move closer to realizing our vision of being a commercial-stage company." Topaz plans to submit its new drug application (NDA) to the FDA in 2011. According to the company, more than 600 patients participated in the two randomized Phase III ivermectin topical cream studies sponsored by Topaz. 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. The company says these studies were conducted in follow-up to favorable Phase II clinical studies that were presented by researchers in July 2010 at the Society for Pediatric Dermatology annual meeting. 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, according to Topaz Pharmaceuticals. 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 onchocerciasis (river blindness) in humans.