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SCOLR Pharma Announces Completion of Patient Enrollment and Dosing for Pivotal Clinical Trial Evaluating Extended Release Ibuprofen
Date:10/9/2008

Top Line Clinical Results Expected in November 2008

BOTHELL, Wash., Oct. 9 /PRNewswire-FirstCall/ -- SCOLR Pharma, Inc. (Amex: DDD) announced today the completion of 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 (ER) ibuprofen for the over-the-counter (OTC) market. 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(R) and Motrin(R), among others, as well as generically.

The Company enrolled and treated approximately 240 patients at a single center in the United States. The randomized, placebo-controlled, double-blind, parallel group study was designed to evaluate the efficacy and safety of multiple doses of ibuprofen 600mg 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 U.S. Food and Drug Administration (FDA) for product approval in the United States. If approved, the Company believes its ibuprofen product would be the first and only OTC 12-hour, extended-release ibuprofen product on the market in the United States. Additional information about the clinical trial can be found at http://www.clinicaltrials.gov. As previously reported, the Company will also be required to complete a label comprehension and consumer use study for product approval prior to submission.

Daniel O. Wilds, the Company's Chief Executive Officer, commented, "We are very pleased with the efficiency in which over 300 potential subjects were recruited and screened to enable the successfu
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SOURCE SCOLR Pharma, Inc.
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