Applied Pharma Research, a Swiss R&D firm specialising in drug delivery, has granted an exclusive license to US drugmaker ProEthic Pharmaceuticals to develop and market two fast-acting formulations of the painkiller diclofenac potassium in the US and Canada.
Diclofenac potassium, a leading non-steroidal anti-inflammatory drug (NSAID), was originally marketed by Novartis in the 1990s for the treatment of rheumatoid and osteoarthritis, dysmenorrhea and mild to moderate pain.
The first formulation, 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. It uses potassium bicarbonate to create a dynamic buffering environment in the gastrointestinal tract that helps facilitate a more rapid and consistent absorption of diclofenac.
As a result, the drug delivery occurs more quickly with a higher peak blood concentration of diclofenac. The new formulation will offer migraine patients exceptionally fast relief with symptomatic improvement beginning in seven to eight minutes after the initial dose. ProEthic expects to file for approval in the US to start trials of the new formulation by the end of the year.
A product based on the technology is currently marketed in Europe by Novartis under the trademark Voltfast.
The second formulation is designed to provide fast, effective relief to patients experiencing mild-to-moderate pain. The patent-pending IRT will deliver a 30 per cent higher plasma level and a time-to-onset that is roughly a third faster than the reference listed drug. ProEthic plans to start clinical trials of the drug in January 2006.
This product is also already marketed in Europe, by Spirig Pharma under the trademark Inflammac Rapid.
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