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SCOLR Pharma's Partner to Commence Bioequivalence Study of Ondansetron
Date:2/14/2012

BOTHELL, Wash., Feb. 14, 2012 /PRNewswire/ -- SCOLR Pharma, Inc. (OTCQB: SCLR) announced today that RedHill Biopharma Ltd., a license partner that had previously obtained the exclusive worldwide rights to use SCOLR's patented technology to develop a new version of ondansetron, will conduct a bioequivalence trial in Canada.  Both the US Food and Drug Administration (FDA) and Health Canada have reviewed the protocol for the study and have no objections.

RedHill 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® (ondansetron), 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.

RedHill Biopharma said publicly, based on advice received from its regulatory consultants, that subject to certain conditions, the study may be considered a pivotal trial (Phase III-equivalent) that may be used by the Company for a marketing application to the FDA.  RedHill Biopharma estimated the development costs of RHB-102, until submission of an application to the FDA, will total $2-3 million. 

Stephen Turner, President and CEO of SCOLR, said: "We believe that the RedHill Biopharma announcement again affirms the potential value of SCOLR's patented technology in developing new pharmaceuticals that improve on existing drugs.  We look forward to a successful outcome on this study and a promising ongoing relationship with 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 deve
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SOURCE SCOLR Pharma, Inc.
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