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 critically important results. In addition to the primary outcomes, we also achieved important secondary endpoints, including confirmed single dose onset of pain relief within one hour of the first dose, and then maintained efficacy over the full twelve hours following the patients' dental surgery."
Turner further stated, "We look forward to sharing the full results and analyses of this study at future business and scientific meetings as we receive the final clinical study report from our contract research organization, AAIPharma, Inc., in early 2009."
Ibuprofen is an analgesic typically used for the treatment of pain, fever and inflammation and is currently sold in immediate-dose products as Advil(R) and Motrin(R), among others, as well as generically. Total global OTC sales of the analgesic market in which the 12-hour ibuprofen product will compete are estimated at more than $8 billion, according to IMS Review Plus data. The Company estimates the annual U.S. sales of immediate-release OTC ibuprofen products exceeds $1 billion.
About the Study
The Company treated 256 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 600 mg ER in dental pain following third 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 consumer use study prior to submission of its U.S. product approval application.
About SCOLR Pharma
Based in Bothell, Washington, SCOLR Pharma, Inc. is a specialty pharmaceutical company. SCOLR Pharma's corporate objective is to combine its formulation expertise and its patented CDT platform to develop novel pharmaceutical, over-the-counter (OTC), and nutritional products. Our CDT drug delivery platform is based on multiple issued and pending patents and other intellectual property for the programmed release or enhanced performance of active pharmaceutical ingredients and nutritional products. For more information on SCOLR Pharma, please call 425.368.1050 or visit http://www.scolr.com/.
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|SOURCE SCOLR Pharma, Inc.|
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