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RedHill received positive results from a comparative bioavailability clinical trial which included 20 healthy volunteers
In light of the positive results, and subject to regulatory requirements, the Company plans to submit, during the third quarter of this year, a European marketing application for RHB-102 for the prevention of chemotherapy and radiotherapy-induced nausea and vomiting in cancer patients
RHB-102 is a proprietary, once-daily, extended release oral pill formulation of the anti-emetic oncology support drug ondansetron
RedHill is also pursuing a new undisclosed indication for RHB-102, which may significantly expand its potential market, with a Phase III study planned to commence in the U.S. later this year
TEL-AVIV, Israel, April 30, 2014 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) (the "Company" or "RedHill"), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage proprietary drugs for the treatment of inflammatory and gastrointestinal diseases and related conditions, today reported positive results from a comparative bioavailability study with RHB-102, a proprietary, extended-release, once-daily oral pill formulation of the anti-emetic oncology support drug ondansetron for the prevention of chemotherapy and radiotherapy-induced nausea and vomiting ("CINV" and "RINV" respectively).
The results of the study are subject to final quality assurance and an independent study report by the Canadian clinical research organization ("CRO") that conducted the study. The final independent report from the CRO is expected in the coming weeks.
The two-arm crossover comparative bioavailability study conducted in Canada followed a positive European scientific advice meeting with the UK Medicines and Healthcare Products Regulatory Agency ("MHRA"), announced on April 7, 2014. The study, which included 20 healthy volunteers, was designed to support the planned European Marketing Authorization Application ("MAA") for RHB-102 and to explore the relative bioavailability between RHB-102 and GlaxoSmithKline's European reference drug. The results of the study demonstrated that the exposure provided by RHB-102 supports its effectiveness and safety.