BELLEVUE, Wash. SCOLR Pharma on Thursday announced the initiation of the first of three trials to evaluate the safety and efficacy of its over-the-counter 12-hour extended-release ibuprofen. 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 Food and Drug Administration in the second half of 2008.
If its ibuprofen product is approved, SCOLR believes its product would be the first and only 12-hour, extended-release ibuprofen product on the market.
“These Phase III trials are a key milestone for SCOLR,” stated Daniel Wilds, SCOLR Pharma’s president and chief executive officer. “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.”