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SCOLR Pharma, Inc. Announces Positive Top-Line Results From Pivotal Clinical Trial Evaluating Efficacy of Extended-Release Ibuprofen
Date:11/6/2008

Pivotal Phase III Trial Primary Endpoints Achieved for SCOLR's 12 Hour Ibuprofen

BOTHELL, Wash., Nov. 6 /PRNewswire-FirstCall/ -- SCOLR Pharma, Inc. (Amex: DDD) today reported favorable top-line results from its pivotal Phase III trial to evaluate the safety and efficacy of its 12 hour CDT(R) 600 mg. extended-release (ER) ibuprofen for the over-the-counter (OTC) market. The trial incorporated FDA special protocol assessment design elements, met both co-primary endpoints (p<0.0001), and had no significant adverse events.

As previously reported, the Company successfully completed two Phase III trials comparing the blood levels of its 12 hour extended-release ibuprofen to three 200 mg Motrin(R) (immediate-release reference standard) tablets. In the current pivotal Phase III efficacy study performed at a single center in the United States, of the 306 patients screened, 256 patients received study medication. This randomized, placebo-controlled, double-blind, parallel group study was designed to evaluate the efficacy and safety of multiple doses of ibuprofen 600 mg ER in dental pain following third molar extraction. The first primary endpoint was to demonstrate analgesic efficacy for the 8-12 hour period after the first dose of SCOLR's ER ibuprofen as compared to placebo. The second primary endpoint measured the durability of effect of SCOLR's formulation by the proportion of subjects in the ibuprofen ER group with meaningful improvement in pain intensity from baseline at all three assessment periods of 24, 36, and 48 hours. Both endpoints achieved positive, statistically significant results, at the p<0.0001 level.

Stephen Turner, the Company's Chief Technical Officer, commented, "We are extremely pleased with these critica
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SOURCE SCOLR Pharma, Inc.
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