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May 22, 2014
08:20 EDTRDHLRedHill Biopharma announces FDA clearance for Phase III study with RHB-102
RedHill Biopharma announced that the FDA has allowed the initiation of the company's planned Phase III clinical study for the treatment of a new, undisclosed indication with RHB-102, an extended release oral pill formulation of the antiemetic drug ondansetron. RedHill plans to begin enrolling patients for the Phase III study during Q3. The double-blind placebo-controlled Phase III study is planned to be conducted in eight clinical sites in the U.S. and will include 320 subjects. Based on prior discussions with the FDA and the UK Medicines and Healthcare Products Regulatory Agency, or MHRA, the study is intended to support potential future submissions of marketing applications for a new undisclosed indication in both the U.S. and Europe. RedHill estimates that, if the Phase III clinical study is successful and the marketing applications are filed and approved by the FDA and the MHRA, the new indication would significantly expand the potential market for RHB-102. In parallel to pursuing the new undisclosed indication, RedHill is pursuing marketing approval of RHB-102 for the indications of chemotherapy and radiotherapy-induced nausea and vomiting in Europe and the U.S.
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March 2, 2015
07:20 EDTRDHLRedHill Biopharma reports two poster presentations for Bekinda
RedHill Biopharma reported the presentation of two posters at the American Society for Clinical Pharmacology and Therapeutics, or ASCPT, 2015 Annual Meeting, to be held between March 3-7, 2015 in New Orleans. The posters describe two previously reported comparative bioavailability studies for Bekinda, a proprietary, extended-release, once-daily oral pill formulation of the antiemetic drug ondansetron. RedHill is developing Bekinda for the indications of gastroenteritis and gastritis as well as chemotherapy and radiotherapy-induced nausea and vomiting. The posters will be presented at the ASCPT meeting by the Canadian Contract Research Organization, or CRO, who conducted the bioavailability studies for RedHill. The first study compared the plasma levels of the active ingredient ondansetron after a dose of Bekinda versus FDA-approved regimens of either Zofran 8 mg given twice daily or as a single 24 mg dose. The randomized, crossover study in 18 healthy volunteers also assessed the accumulation of ondansetron in plasma after administering five consecutive daily doses of Bekinda under fasting conditions, as well as the safety and tolerability of Bekinda. The results of the study demonstrated that the plasma levels of ondansetron after Bekinda were similar or higher than the plasma levels after Zofran 8 mg b.i.d, thus indicating that the efficacy of Bekinda is at least as good as Zofran 8 mg b.i.d. The study further demonstrated that the safety and tolerability of Bekinda were similar to the safety profile of the FDA-approved regimens of ondansetron. The second comparative bioavailability study evaluated the influence of food on the pharmacokinetics of Bekinda in healthy volunteers. The randomized, crossover study demonstrated that, consistent with the commercially available Zofran 8 mg immediate-release formulation, food delayed the absorption of Bekinda and increased the maximal concentrations and extent of absorption of the ondansetron. Despite these increases, which are not expected to have clinical significance, the number and severity of adverse events were lower under fed conditions.
February 26, 2015
07:54 EDTRDHLRedHill Biopharma reports Q4 EPS 6c, may not compare to two estimates (60c)

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