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Gastroenteritis & Gastritis

BEKINDA® (RHB-102) is a proprietary, oral, extended-release (24 hours), once-daily pill formulation of the antiemetic drug ondansetron. 

Acute gastroenteritis and gastritis are inflammations of the mucus membranes of the gastrointestinal tract, most commonly caused by a viral infection. Symptoms of gastroenteritis include nausea, vomiting, diarrhea and abdominal pain.

RedHill announced positive results from a randomized, double-blind, placebo-controlled, parallel group Phase III clinical study in the U.S. The study evaluated the safety and efficacy of BEKINDA® 24 mg in patients suffering from acute gastroenteritis (the GUARD study).

The study successfully met its primary endpoint of efficacy in treatment of acute gastroenteritis. BEKINDA® was found to be safe and well tolerated in this indication.

The GUARD study is intended to support potential future submissions of marketing applications in both the U.S. and Europe for this indication. If approved for marketing by the FDA, BEKINDA® could become the first-ever 5-HT3 antiemetic drug indicated for the treatment of acute gastroenteritis.

The GUARD Phase III study is registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health which provides public access to information on publicly and privately supported clinical studies.