Based on recent feedback from the FDA and prior feedback from UK regulators, RedHill Biopharma (NASDAQ:RDHL) says that results, if significantly positive, from its ongoing Phase 3 study, GUARD, evaluating BEKINDA (ondansetron) in acute gastroenteritis and gastritis may be sufficient to support regulatory filings in the U.S. and EU. Based on the FDA's guidance, the company filed a protocol amendment to increase data collection (increase U.S. clinical sites to 30 from 12) and add additional safety tests. The company expects to have top-line results in mid-to-late 2016. If approved, BEKINDA will be the first 5-HT3 antiemetic (prevents nausea and vomiting) drug indicated for the treatment of acute gastroenteritis and gastritis.
RedHill filed a Marketing Authorization Application (MAA) with the EMA in late 2014 seeking clearance for BEKINDA for the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting.
The company plans to initiate a Phase 2 study assessing BEKINDA for the treatment of irritable bowel syndrome with diarrhea no later than Q1.
Previously: RedHill's European MAA for Bekinda accepted (Dec. 31, 2014)
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