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June 14 Israel-based RedHill Biopharma Ltd said its experimental drug for the treatment of gastroenteritis met the main goal in a late-stage study.
Gastroenteritis is the inflammation of the stomach and intestines that causes vomiting and diarrhea. The trial tested the efficacy and safety of the drug, bekinda, compared with a placebo, in 321 patients suffering from the condition.
Bekinda is a once-daily oral pill formulation of the existing anti-nausea drug ondansetron and is designed to provide relief from nausea and vomiting symptoms for a 24-hour period.
Data showed Bekinda can provide patients with 24 hours of relief and works regardless of the initial severity of gastroenteritis, the company said.
RedHill is still analyzing the dataset and plans to discuss the path to approval with the Food and Drug Administration, it added on Wednesday.
Gastroenteritis is a very common illness in the United States, with about 179 million cases annually, and can be caused by many different infectious agents, typically viral infections, according to the Centers for Disease Control & Prevention.
Data from a mid-stage study testing bekinda in patients with diarrhea-predominant irritable bowel syndrome is expected in September.
U.S.-listed shares of Tel Aviv-based company rose about 5 percent at $9.92 in early trading on Wednesday. (Reporting by Natalie Grover in Bengaluru; Editing by Anil D'Silva)
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