BELLEVUE, Wash., Aug. 6 /PRNewswire-FirstCall/ -- SCOLR Pharma, Inc. (Amex: DDD) announced today that it has submitted to the Food and Drug Administration an Abbreviated New Drug Application (ANDA) for a 120 milligram 12-hour pseudoephedrine tablet based on the Company's patented Controlled Delivery Technology (CDT(R)) platform. This is the first application submitted by SCOLR based on its CDT platform.
Pseudoephedrine is an active ingredient in Allegra(R) D, Sudafed(R) PSE, Claritin(R) D, Zyrtec(R) D and other over-the-counter (OTC) and prescription products as a decongestant. The domestic OTC decongestant market for pseudoephedrine-containing products is estimated to exceed $1 billion annually.
Stephen J. Turner, SCOLR's Vice President and Chief Technical Officer, stated, "We believe the primary advantages our formulation may have over currently marketed pseudoephedrine tablets relates to the overall efficiency of the formulation. We were able to demonstrate bio-equivalence for our product while significantly reducing the overall tablet size, gaining important manufacturing margin advantages over currently available tablets.
"Since pseudoephedrine tablets now face marketing pressure because of required placement behind the counter in the pharmacy, we believe that margin and size may play an important role in the selection process for consumers, and could give SCOLR an advantage in the competitive store-brands and private label marketplace."
"The ANDA for pseudoephedrine is a major accomplishment for SCOLR," said Daniel O. Wilds, the Company's Chief Executive Officer. "Approval of this product would further substantiate some of the unique advantages of our drug delivery technology and can be an important revenue contributor to our business in the future."
Wilds added: "Submission of the ANDA is the second major SCOLR initiative this summer. We previously announced the initiation of the third of three pivotal trials to evaluate the safety and efficacy of our formulation of 12-hour extended-release (ER) ibuprofen."
The Company expects to complete the ibuprofen trial late this year. 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.
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/.
This press release contains forward-looking statements (statements
which are not historical facts) within the meaning of the Private
Securities Litigation Reform Act of 1995, including without limitation
statements related to potential revenues, the outcome and timing of
clinical and pre-clinical studies, the timing and success of regulatory
applications and market acceptance of new products. These forward-looking
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successfully develop new formulations and complete research and
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trials are not successful or take longer to complete than we expect, we may
not be able to develop and commercialize our products and we may not obtain
regulatory approval for our products, which would materially impair our
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actual results or developments may differ materially from those set forth
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|SOURCE SCOLR Pharma, Inc.|
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