BOTHELL, Wash., April 9, 2012 /PRNewswire/ -- SCOLR Pharma, Inc. (OTCQB: SCLR) announced today that RedHill Biopharma Ltd., which has licensed the exclusive worldwide rights to use SCOLR's patented technology to develop an extended release version of the anti-emetic drug ondansetron (brand name Zofran®), has received positive preliminary results in a pharmacokinetic (PK) study comparing its version of ondansetron with Zofran®. RedHill said that, assuming the final clinical study report supports the preliminary findings, it will consider filing an application with the FDA for US marketing approval (New Drug Application – NDA) utilizing the clinical study as a pivotal clinical trial.
RedHill announced that the initial analysis of the results indicates that the clinical study has met its objective of establishing bioequivalence to Zofran®, the current approved reference listed drug. RedHill said it will provide further updates on the next steps it will take for continued commercial development, following receipt of the final clinical study report and detailed analysis.
As previously announced, RedHill had submitted an Investigational New Drug application (IND) to the FDA and a Clinical Trial Application (CTA) to Health Canada seeking permission to compare the bioequivalence of its product, which it calls RHB-102, to Zofran®, which is manufactured by GlaxoSmithKline. Zofran® is an anti-emetic drug (i.e. for prevention of nausea and vomiting) that is administered several times per day. RHB-102 is a once-daily controlled release tablet formulation of ondansetron, a serotonin 5-HT3 receptor antagonist.
Stephen Turner, President and CEO of SCOLR, said: "We are encouraged that preliminary results look promising for this extended release version of a very important and frequently prescribed drug. This outcome provides further evidence of the potential of our CDT® Controlled Delivery Technology platform to create opportunities for the development of extended release pharmaceutical products. We hope for continued success with our partner RedHill."
About SCOLR Pharma:
Based in Bothell, Washington, SCOLR Pharma, Inc. is a specialty pharmaceutical company focused on applying its formulation expertise and patented CDT® platforms to develop novel prescription pharmaceutical, over-the-counter (OTC), and nutritional products. Its CDT® drug delivery platforms are 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 425-368-1050 or visit http://www.scolr.com/.
About RedHill Biopharma Ltd.:
RedHill Biopharma is an emerging Israeli biopharmaceutical company focused primarily on development and acquisition of late clinical-stage new formulations and combinations of existing drugs. RedHill Biopharma's current product pipeline includes a once-daily formulation of a leading congestive heart failure and high blood pressure drug, a once-daily formulation of a leading radiotherapy induced nausea and vomiting prevention drug, an oral thin film formulation of a leading triptan for the treatment of acute migraine, a combination therapy for the treatment of MAP infection in Crohn's as well as a companion diagnostic test for detection of the MAP bacteria, a combination treatment against resistant H. pylori bacteria causing ulcers, and a patent protected encapsulated formulation for bowel preparation ahead of certain gastro procedures. RedHill Biopharma's team includes prominent pharmaceutical experts. For more information please visit: www.redhillbio.com.
Forward looking statements:
Any statements made in this press release that relate to future plans, events or performance are forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward looking statements include statements regarding RedHill Biopharma's development of a drug formulation, preliminary analysis of results of a bioequivalence study, and anticipated future plans related to the development and marketing of the drug formulation. Factors that could cause these forward-looking statements to differ from actual results include results of further detailed analysis on the results of the bioequivalence study, adverse clinical results or adverse regulatory determinations related to the study, competitive factors related to the drug product, economic factors including RedHill's ability to finance the development and commercialization of the product, and other risks and uncertainties discussed in the company's periodic reports on Form 10-K and 10-Q and other filings with the Securities and Exchange Commission. SCOLR Pharma, Inc. undertakes no obligation to update or revise any forward-looking statements.
SCOLR Pharma, Inc.
SOURCE SCOLR Pharma, Inc.