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news.RedHill Biopharma has reported positive results in an advanced bioequivalence clinical trial with RHB-102 for the prevention of nausea and vomiting in cancer patients.
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The trial met its objectives and FDA’s criteria for bioequivalence between RedHill’s once daily RHB-102, and GlaxoSmithKline’s Zofran.
RHB-102 is designed to prevent nausea and vomiting over 24 hours in order to avoid the need for additional drug administrations during the 24 hours post-treatment.
RedHill Corporate & Product Development VP Gilead Raday said: "We intend to request a pre-NDA meeting with the FDA in the coming weeks to discuss a US NDA marketing approval application for RHB-102."