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news.RedHill Biopharma, a license partner of SCOLR Pharma, will conduct bioequivalence trial of ondansetron in Canada.
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The study protocol was reviewed and cleared by the FDA and Health Canada.
RedHill has submitted an IND to the FDA and Clinical Trial Application (CTA) to Health Canada seeking approval to compare the bioequivalence of its product, RHB-102, to Zofran(ondansetron).
RHB-102 is a once-daily controlled release tablet of ondansetron, a serotonin 5-HT3 receptor antagonist.
Zofran is an anti-emetic drug, indicated for the prevention of nausea and vomiting, that is administered several times per day.
SCOLR president and CEO Stephen Turner said RedHill Biopharma announcement affirms the potential value of SCOLR’s patented technology in developing new pharmaceuticals that improve on existing drugs.