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news.Scolr Pharma has initiated the third of 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 enroll approximately 240 patients at a single center in the US. This randomized, placebo-controlled, double-blind, parallel group study is designed to evaluate the efficacy and safety of multiple doses of ibuprofen 600mg extended-release in dental pain following molar extraction. It is anticipated that the data from this trial will be used to support application to the FDA for product approval in the US.
The company expects to complete the trial in late 2008. 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.
Ibuprofen is an analgesic typically used for the treatment of pain, fever and inflammation. It is sold in immediate-dose products as Advil and Motrin, among others, as well as generically.