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Following a successful comparative bioavailability trial, the Company met with the FDA to discuss its planned New Drug Application (NDA) filing for RHB-102
Company plans to file the RHB-102 NDA in Q4/2013
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, Feb. 25, 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 recently concluded a Type B meeting and has held additional communications with the U.S. Food and Drug Administration ("FDA") regarding RedHill's 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 purpose of these communications with the FDA was to discuss the filing of a U.S. new drug application ("NDA") for RHB-102, following the Company's 2012 comparative bioavailability study. Based on these communications and subject to additional regulatory and other activities, RedHill currently estimates that an NDA for RHB-102 will be filed during the fourth quarter of 2013. In the meantime, RedHill is focused on completing additional studies and product information required for the NDA data package and plans to seek additional regulatory guidance from the FDA ahead of the planned NDA submission.
With potentially significant advantages to cancer patients over the immediate release oral ondansetron tablets, RHB-102 is targeting a significant segment of the 5-HT3 anti-emetic oncology support drug products' market, which was estimated to be approximately $1 billion in 2010 by BCC Research, a leading market intelligence and information resource.