Navigation Links
SCOLR Pharma, Inc. Submits Abbreviated New Drug Application for a 12-hour CDT-based Pseudoephedrine Formulation
Date:8/6/2008

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 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 http://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.

Contacts:

Investor Relations:

Cameron Associates

Kevin McGrath

212.245.4577

Kevin@cameronassoc.com


'/>"/>
SOURCE SCOLR Pharma, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Why Do Drugs Cost So Much? and why are we so darn sick?: New Book Reveals Inner Workings of Big Pharma, Asks Hard Questions About Our Health
2. Galderma Pharma, S.A. and ZARS Pharma, Inc. Extend Agreement to Cover Worldwide Rights for Pliaglis(TM)
3. Legislative and Regulatory Outlook - 2009 and Beyond for Pharma, Biotech Players
4. TyRx Pharma, Inc. Announces Presentation of Results to Benefit Women with Breast Implants (In-Vivo Efficacy Study Regarding AIGISRx DEB) at the Plastic Surgery 2007 Meeting on October, 28 2007 in Baltimore, MD
5. GeoPharma, Inc. to Present at the EdgeWater Research Investor Conference
6. TriServ Alliance Submits Bid for TRICARE South Region Contract
7. Labopharm Submits Complete Response to FDA as a Result of Outcome of Appeal Process for Once-Daily Tramadol
8. Centocor, Inc. Submits Application to FDA Requesting Approval of Golimumab for the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
9. AstraZeneca submits an sNDA for Symbicort for treatment of asthma in children as young as 6
10. Abbott Submits Application for Approval of XIENCE(TM) V Everolimus Eluting Coronary Stent System in Japan
11. Leiner Health Products Submits Proposed Agreement with Department of Justice to U.S. Bankruptcy Court for Approval
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/24/2017)... ... , ... “Journey to the Light: The Quest for Happiness and Love. . ... to finding herself. “Journey to the Light: The Quest for Happiness and Love. ... writer of newsletters, manuals, and articles, who has recently decided to expand her literary ...
(Date:7/23/2017)... (PRWEB) , ... July 23, 2017 , ... A ... in St. Louis, and led by the Minneapolis Veterans Administration Health Care System overwhelmingly ... of the disease offers very few benefits. , In the cases involved with ...
(Date:7/23/2017)... ... 23, 2017 , ... Technology is making it easier for ... tools are helping patients become more actively involved in their care and maintaining ... survey, released today by the American Hospital Association’s (AHA) Health Forum. , According ...
(Date:7/23/2017)... ... July 23, 2017 , ... Viora Ltd., a ... US Patent No. 9,038,640 by the United States Patent and Trademark Office. The ... combination of Switching, Vacuum, and Cooling mechanisms to further increase the efficacy and ...
(Date:7/21/2017)... ... July 21, 2017 , ... "As a doctor of lung medicine ... catheters available on the market," said an inventor from Center Valley, Pa. "My idea ... the patient." , He developed the patent-pending PLEURAL SAFE-t-STAT CATHETER KIT to offer an ...
Breaking Medicine News(10 mins):
(Date:7/11/2017)... 11, 2017  The global market for liquid biopsy ... $394.1 million in 2016.  Although in early stages, the ... in particular as a result of the gradual shift ... recent introduction of a significant number of new liquid ... of tumor biomarkers to guide treatment decisions. ...
(Date:7/10/2017)... , July 10, 2017 The Institute for ... methods, is the recipient of a VITROCELL® inhalation exposure ... International Science Consortium. The device, which is designed to ... expose human lung cells to airborne test materials in ... use the VITROCELL® system for testing combustible tobacco products, ...
(Date:7/5/2017)... 5, 2017 Wolfmet 3D  printed tungsten collimator manufactured by ... and manufacturing combine to progress molecular radiotherapy imaging. ... are unable to accurately quantify the radiation absorbed by those ... the success of this radiotherapy treatment has been available — ... ...
Breaking Medicine Technology: