APR licenses fast-acting diclofenac to ProEthic

Applied Pharma Research, a Switzerland-based R&D firm that specializes in enhancing drug delivery, has granted an exclusive license to US drugmaker ProEthic to develop and market two fast-acting formulations of diclofenac potassium in the USA and Canada.

ProEthic will develop and market the formulations in the USA as 505(b)2 applications. The first, designed to treat migraine headaches, contains 50mg of diclofenac potassium in a powder formulation and incorporates a unique, patent-pending immediate-release technology developed by APR. Shown to enhance the pharmacokinetics of diclofenac, IRT uses potassium bicarbonate to create a dynamic buffering environment in the gastrointestinal tract that helps facilitate a more rapid and consistent absorption of diclofenac. ProEthic has scheduled a pre-Investigational Drug for October 19 and anticipates filing an IND by year-end. The product is currently marketed in Europe by Novartis under the trademark Voltfast.

The second formulation will provide fast, effective relief to patients experiencing mild-to-moderate pain. The patent-pending IRT will deliver a 30% higher plasma level and a time-to-onset that is roughly 30% faster than the reference listed drug. ProEthic has completed a pre-IND and plans to file the IND in the fourth quarter of 2005. Two clinical trials are scheduled and will commence in January, 2006.