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news.RedHill Biopharma, SCOLR Pharma's partner, has received positive preliminary results in a pharmacokinetic (PK) study comparing its version of ondansetron with Zofran.
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The study has met its objective of establishing bioequivalence to Zofran, the current approved reference listed drug.
RedHill expects to file an application with the FDA for US marketing approval utilizing the clinical study as a pivotal trial.
Zofran is an anti-emetic drug 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.
SCOLR president and CEO Stephen Turner said:"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."