The study is a single-center, randomized, placebo-controlled, double-blind, parallel group assessment of the multiple-dose efficacy of ibuprofen 600mg ER, enrolling approximately 150 patients. The primary objective is to evaluate the efficacy and safety of multiple doses of ibuprofen 600mg ER in a study of dental pain following extraction of third molar teeth.
Ibuprofen is an analgesic typically used for the treatment of pain, fever and inflammation. The company expects to complete the trials by the end of the first quarter of 2008, and plans to file a new drug application with the FDA in the second half of 2008.
Daniel Wilds, president and CEO of Scolr Pharma, said: “These Phase III trials are a key milestone for Scolr. They represent an important step toward achieving our goal of providing an OTC 12-hour CDT-based formulation of ibuprofen. We believe the substantial in vivo data accumulated from previous trials, together with our development and successful scale-up activities, demonstrate commercial viability for our product, and we look forward to successful completion of these studies and eventual approval by the FDA.”