Topaz Pharmaceuticals Inc., a privately held specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) accepted for filing the New Drug Application (NDA) for the use of ivermectin topical cream as a treatment for head lice infestations in children and adults.
"This filing represents the transition of the Company from the development phase as we are now preparing to commercialize our lead product candidate," said Robert Radie, chief executive officer and president of Topaz. "Current treatment options are limited by one or more of 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 United States. With the potential for our lead product to be the first ivermectin formulation for the treatment of head lice, we believe we can improve the experience individuals and their families have during a head lice infestation."
Topaz submitted the NDA for ivermectin cream to the FDA on April 7, 2011. Acceptance of the NDA for review represents the FDA's determination that the application is sufficiently complete to permit a substantive review of the data. The acceptance of the application by the FDA does not represent any opinion regarding the safety, efficacy or approvability of ivermectin cream. Under PDUFA (Prescription Drug User Fee Act) it is the FDA's goal to review and act on this NDA by February 7, 2012.
The NDA submitted by Topaz included data from two randomized double blind phase 3 clinical trials that compared 0.5% ivermectin cream with a vehicle control (placebo). Ivermectin topical cream or placebo was dispensed to clinical trial participants six months of age and older for application to dry hair and scalp followed by a rinsing after 10 minutes. The primary efficacy endpoint used in 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 also were evaluated for safety and local tolerability. These studies were conducted in follow-up to favorable clinical studies that were presented by researchers in July 2010 at the Society for Pediatric Dermatology annual meeting. In total, data from seven clinical studies including more than 900 subjects receiving active drug product were included in the NDA submitted to the FDA.
Topaz Pharmaceuticals Inc.