BELLEVUE, Wash., Aug. 6 /PRNewswire-FirstCall/ -- SCOLR Pharma, Inc. 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 statements involve risks and uncertainties, including activities, events or developments that we expect, believe or anticipate will or may occur in the future. A number of factors could cause actual results to differ from those indicated in the forward- looking statements, including our ability to successfully develop new formulations and complete research and development, including pre-clinical and clinical studies, our ability to raise additional funds, the continuation of arrangements with our product development partners and customers, competition, government regulation and approvals, and general economic conditions. For example, if our clinical 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 ability to generate revenue. Additional assumptions, risks and uncertainties are described in detail in our registration statements, reports and other filings with the Securities and Exchange Commission. Such filings are available on our website or at www.sec.gov. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances.
CONTACT: Investor Relations: Kevin McGrath of Cameron Associates,
+1-212-245-4577, Kevin@cameronassoc.com, for SCOLR Pharma, Inc.
Web site: http://www.scolr.com/
