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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."