PipelineReview.com - Biotech News & Online Store - SCOLR Pharma Reports Positive Ondansetron Clinical Results, New Drug Development Targets, and Revised Development Priorities

SCOLR Pharma Reports Positive Ondansetron Clinical Results, New Drug Development Targets, and Revised Development Priorities

16 Feb 2006

BELLEVUE, WA, USA | Feb 16, 2006 | SCOLR Pharma, Inc. (Amex: DDD) announced today that it has successfully completed

pilot bioavailability testing in Canada of its Controlled Delivery Technology (CDT(R)) extended release ondansetron tablets. This is the second application of its amino acid technology. The testing results provide further evidence that SCOLR's patented amino acid CDT-based platform may be a viable alternative to currently utilized solubility and permeability-enhancing practices.

Ondansetron hydrochloride is the active ingredient in Zofran(R), GlaxoSmithKline's tablet and injection formulations to prevent chemotherapy and radiation related nausea and vomiting. In 2005, GlaxoSmithKline reported over $1.5 billion in global Zofran sales. Commercially available Zofran 8 milligram (mg.) and 24 mg. tablets served as the controls for SCOLR Pharma's pilot study.

The Company's ondansetron pilot testing consisted of a 30-subject, randomized, five-way cross-over, and open-label fasting design. It compared three prototype extended release 24 mg. CDT amino acid-based ondansetron tablet formulations to 8 mg. and 24 mg. immediate release Zofran(R) tablets. The results indicate the CDT-based non-optimized tablet formulations may provide higher initial blood levels and extended drug release as compared to the 8 mg. Zofran tablet.

Stephen J. Turner, SCOLR Pharma's Chief Technical Officer, said "We are very encouraged by the results from this second application of our amino acid technology. The data we are collecting in these trials strengthen the value of our approach to solubility and permeability enhancement."

Turner further noted, "On the basis of these positive results, we plan to optimize our raloxifene and ondansetron formulations for continued evaluation and to expand the application of our amino acid technology to two new drug targets. The new targets include developing novel formulations of fenofibrate and gabapentin. Our goal with these new formulations will be to offer tangible improvements over the current commercial products.

Due to our licensing the use of CDT technology for ibuprofen products to Wyeth, we discontinued development of an ibuprofen-pseudoephedrine combination product. In addition, we suspended the development of a 24 hour extended release pseudoephedrine formulation pending an evaluation of changes in the market for products containing pseudoephedrine and the impact of regulatory authority restrictions on the sale and marketing of such products. As a result of these changes, we intend to prioritize and leverage our recent work to develop an extended release phenylephrine formulation to complement our OTC portfolio of CDT-based analgesics and decongestants. We expect to initiate clinical testing on all new CDT development targets later this year."

Fenofibrate is the active ingredient in Tricor(R), an Abbott product for hypercholesterolemia (elevated total cholesterol). In 2004, Abbott's global Tricor sales were approximately $779 million and it is estimated that the fenofibrate market could double over the next few years.

Gabapentin is the active ingredient in Neurontin(R), a Pfizer product for neuralgia (neural pain) and as an adjunct treatment of partial seizures associated with epilepsy. In 2005, Pfizer's domestic Neurontin sales were approximately $639 million and expected to be further negatively impacted by generic competition in future years.

Phenylephrine is a substitute ingredient for pseudoephedrine and the active ingredient in Sudafed(R) PE, an immediate release Pfizer OTC decongestant product for upper respiratory discomfort. Phenylephrine is also the active ingredient in multiple new private label store brand products for similar indications. The domestic OTC decongestant market is estimated to exceed $1 billion annually.

Based in Bellevue, Washington, SCOLR Pharma, Inc. is a specialty pharmaceutical company leveraging formulation expertise and its patented CDT platform to introduce distinctive and novel OTC products, prescription drugs and dietary supplements. SCOLR Pharma's CDT drug delivery platform provides distinctive products with tangible benefits for the consumer and competitive commercial advantages for licensees. 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. These forward-looking statements involve risks and uncertainties, including activities, events or developments that the Company expects, believes or anticipates 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 the Company's ability to successfully develop new formulations and complete research and development, including pre-clinical and clinical studies, the Company's ability to raise additional funds, the continuation of arrangements with the Company's product development partners and customers, competition, government regulation and approvals, and general economic conditions. 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. Readers 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. The Company undertakes no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances.

Copyright (C)2006 SCOLR Pharma, Inc. All Rights Reserved.

SOURCE: SCOLR Pharma, Inc.

Search in our News Channels

Search in our Online Store