Topaz Pharmaceuticals

Announces Completion of Pivotal Phase 3 Trials of Ivermectin Topical Cream

Topaz Pharmaceuticals Inc., a privately held specialty pharmaceutical company, announces 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).
“Parents and caregivers are looking for safe and effective treatments for head lice,” said Thomas Beck, M.D., chief medical officer at Topaz. “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 six million people, mostly school aged children who are impacted by lice each year in the U.S. The completion of our two Phase 3 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.”

More than 600 patients participated in the two randomized Phase 3 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 six 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. These studies were conducted in follow-up to favorable Phase 2 clinical studies that were presented by researchers in July 2010 at the Society for Pediatric Dermatology annual meeting.