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Following a Type B meeting with the FDA in February 2013, the Company commenced the first of two supplementary pharmacokinetic studies with RHB-102, with a second comparative bioavailability study planned to commence next month
The Company expects to receive results from both studies by October 2013, and plans to file a New Drug Application (NDA) for RHB-102 in the first quarter of 2014, earlier than previously planned
RHB-102 is a proprietary, extended release, once-daily oral formulation of ondansetron, a leading drug for the prevention of nausea and vomiting in cancer patients
TEL-AVIV, Israel, July 11, 2013 (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, patent-protected, new formulations and combinations of existing drugs, reported that it had commenced dosing in the first of two supplementary pharmacokinetic studies with RHB-102, a patent protected, oral, extended-release (24 hours) formulation of ondansetron. Ondansetron is the active ingredient in GlaxoSmithKline's Zofran® immediate release tablets for the prevention of radiotherapy induced nausea and vomiting (RINV) and chemotherapy induced nausea and vomiting (CINV).
The supplementary pharmacokinetic studies follow a Type B meeting held with the FDA in February 2013. The first pharmacokinetic study, conducted in Canada, includes 14 healthy volunteers and is intended to assess the effect of food on the absorption of RHB-102. The Company also plans to initiate, in August 2013, a supplementary comparative bioavailability clinical study with RHB-102, with Zofran® immediate release tablets as the reference drug.
Based on the planned dosing schedule for the pharmacokinetic studies, the Company anticipates that the results of the studies will be available by October 2013. Subject to the results from the two studies and the required regulatory process, and in light of the data from prior successful studies with RHB-102, the Company plans to submit a New Drug Application (NDA) seeking U.S. marketing approval of RHB-102 in the first quarter of 2014, earlier than previously planned.