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SCOLR Pharma announced the initiation of the third of 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
BELLEVUE, WA, USA | July 1, 2008 | SCOLR Pharma, Inc. (AMEX: DDD - News) announced the initiation of the third of 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 complete the trial in late 2008. 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. Ibuprofen is an analgesic that is sold in immediate-dose products as Advil® and Motrin®, among others, as well as generically.
The Company expects to enroll approximately 240 patients at a single center in the United States. This randomized, placebo-controlled, double-blind, parallel group study is 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 application to the U.S. Food and Drug Administration for product approval in the United States. Additional information about the clinical trial can be found at www.clinicaltrials.gov. As previously reported, the Company will also be required to complete a label comprehension and consumer use study for product approval.
Daniel O. Wilds, the Company’s Chief Executive Officer, commented, “The final protocol for this trial reflects the previously announced special protocol assessment guidance from the FDA and represents a significant milestone for SCOLR in advancing development of its extended-release ibuprofen.”
Ibuprofen is an analgesic typically used for the treatment of pain, fever and inflammation. 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 SCOLR Pharma
Based in Bellevue, 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 425.373.0171 or visit http://www.scolr.com/.
SOURCE: SCOLR Pharma, Inc. |
