The NDA, submitted on 7 April 2011, includes data from two randomized double blind phase 3 clinical trials that compared 0.5% ivermectin cream with a vehicle control (placebo).
Achieving ‘lice free’ status within 24 hours of application and maintaining it for at least a fortnight after application was the primary efficacy endpoint.
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 president and CEO Robert Radie said this filing represents the transition of the company from the development phase as they are now preparing to commercialize their lead product candidate.
"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," Radie said.