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news.Scolr Pharma has reported two additional positive pharmacokinetics trials evaluating its extended-release over-the-counter ibuprofen product and it intends to submit the drug for approval in 2008.
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Scolr Pharma is also making available previously non-disclosed information about progress of its product with the potential to be the first extended-release ibuprofen tablet formulation for the US over-the-counter market.
The company reacquired all rights to use its technology for products containing ibuprofen, following Wyeth's termination of the global license and development agreement in April, 2007.
Steven Turner, vice president, said: “In both clinical studies reported today, the subjects' ibuprofen blood levels met the requirements that we believe will be required for eventual US regulatory approval.”
Scolr Pharma said despite Wyeth's decision to terminate their alliance, it believes it is now in a position to more rapidly advance its clinical program.