SCOLR Pharma Ends Development Of Extended-Release Nasal Decongestant
BELLEVUE, Wash. -- SCOLR Pharma, Inc. today announced positive preliminary results from pilot bioavailability testing of its refined 24-hour CDT-based ondansetron tablets. The Company also reported that it will no longer continue the development of a 12-hour CDT-based phenylepherine formulation.
SCOLR Pharma previously announced the completion of a 29 subject, randomized, four-way crossover, open-label, fasting design test of its further refined CDT-based ondansetron tablets in late 2006. Stephen Turner, SCOLR Pharma's Vice President and Chief Technology Officer, said, "The data from this second ondansetron study provides additional evidence that our CDT formulation technology is capable of producing a 'once daily' sustained release tablet. We intend to provide additional information on our trial results later this year at future investor conferences and at the Annual Controlled Release Society Meeting in Long Beach, California." Turner further noted, "The unique nature of this compound will require further investigation, but the data from this most recent study provides the basis for us to proceed with final product optimization and subsequent confirmation studies."
Ondansetron hydrochloride is the active ingredient in Zofran®, GlaxoSmithKline's drug to prevent chemotherapy and radiation related nausea and vomiting. In 2005, GlaxoSmithKline reported over $1.5 billion in global Zofran® sales. In the past several months, several generic 8 milligram (mg) immediate release ondansetron products have been approved by the FDA. Commercially available Zofran 8 mg. tablets served as the controls for SCOLR Pharma's CDT-ondansetron study.
SCOLR Pharma also reported that the recently completed clinical testing of its initial, non-optimized CDT-based extended release phenylepherine tablets has provided valuable data but does not justify continued internal development. Based on the recent interest in use of phenylepherine as a replacement or substitute compound to pseudoephedrine, the pharmaceutical industry has been actively converting immediate release pseudoephedrine containing products to ones containing phenylepherine. However, the industry has not yet produced an extended release, solid oral dosage form of phenylepherine. Turner stated, "Although we have gained valuable insight into the challenges of formulating an extended release phenylepherine product, including metabolism issues associated with the compound, the preliminary test results do not merit further additional investment at this time. While we believe our platform has the potential to overcome these development hurdles, we plan to focus our resources on our extended release formulation of pseudoephedrine with the goal of filing an Abbreviated New Drug Application with the FDA later this year."
Daniel O. Wilds, President and CEO of SCOLR Pharma, said, "While we are disappointed that our initial work on an extended release phenylepherine formulation does not support further commercial development, the successful completion of our second ondansetron study represents the achievement of another important milestone for our Company. The results from our ondansetron study further demonstrate the applicability of our CDT technology to a growing number of challenging compounds and support our optimism that it can be successfully utilized to formulate a broad range of orally-administered pharmaceuticals."
About SCOLR Pharma, Inc.
Based in Bellevue, Washington, SCOLR Pharma, Inc. is a specialty pharmaceutical company. SCOLR Pharma's corporate objective is to combine its formulation expertise and patented CDT platform to develop novel pharmaceutical, over-the-counter (OTC), and nutritional products. Our CDT platform is based on four recently patented drug delivery technologies for the programmed release of solid oral medications and nutritional products. For more information on SCOLR, 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 we expect, believe of 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.
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Contact: Investor Relations: Cameron Associates Kevin McGrath, 212-245-4577 [email protected]