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news.Scolr Pharma, a specialty pharmaceutical company, has completed patient enrollment and dosing for the third of its three pivotal trials to evaluate the safety and efficacy of its formulation of 12-hour extended-release ibuprofen for the over-the-counter market.
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The company expects to report top-line results from this pivotal trial in November 2008. Ibuprofen is an analgesic that is sold in immediate-dose products as Advil and Motrin, among others, as well as generically. It is used for the treatment of pain, fever and inflammation.
The company has enrolled and treated approximately 240 patients at a single center in the US. The randomized, placebo-controlled, double-blind, parallel group study was designed to evaluate the efficacy and safety of multiple doses of ibuprofen 600mg extended-release (ER) in dental pain following molar extraction.
It is anticipated that the data from this trial will be used to support a submission to the FDA for product approval in the US. If approved, the company believes its ibuprofen product would be the first and only over-the-counter 12-hour, extended-release ibuprofen product on the market in the US.
Daniel Wilds, CEO of Scolr Pharma, said: “We are very pleased with the efficiency in which over 300 potential subjects were recruited and screened to enable the successful and timely dosing of our targeted study population. The attainment of this clinical study milestone is an important measure of our success in advancing this exciting project and we look forward to announcing study results later in 2008.”