Acute gastroenteritis and gastritis are characterized by inflammation of the mucus membranes of the gastrointestinal tract, most commonly caused by viral infection, with symptoms including nausea, vomiting, diarrhea and abdominal pain.
RHB-102 (BEKINDA®) is a once-daily, 24-hr, bimodal release, oral tablet formulation of the antiemetic drug ondansetron, a 5-HT3 antagonist.
RedHill successfully completed a U.S. Phase 3 study (the GUARD study) with RHB-102 (24 mg) in patients with acute gastroenteritis and gastritis, meeting the primary efficacy and safety endpoints.
If approved for marketing, RHB-102 could become the first 5-HT3 antiemetic drug indicated for the treatment of acute gastroenteritis or gastritis in the U.S.
Read more about the study results here.