Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today announced completion of patient enrollment in the company's two ongoing Phase III clinical trials studying eluxadoline for the treatment of diarrhea-predominant irritable bowel syndrome, or IBS-d. Both studies met their target enrollments and Furiex expects to release top line results in the first quarter of 2014.
“We believe there is an unmet need for IBS-d treatment that has efficacy in both pain and diarrhea, with good tolerability and a convenient dosing schedule.”
The two Phase III trials have the same overall design and efficacy endpoints, but differ in overall duration. One study has a 52-week treatment period and the other a 30-week treatment period. Each study has three treatment arms, placebo, 75 mg eluxadoline twice a day and 100 mg eluxadoline twice a day, with approximately 375 patients per arm, and is designed to capture both the U.S. Food and Drug Administration and the European Medicines Agency endpoints for treatment of IBS-d.
"Final completion of enrollment in the Phase III clinical trials for eluxadoline brings us one step closer to our goal of submitting a New Drug Application," said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex, "We believe there is an unmet need for IBS-d treatment that has efficacy in both pain and diarrhea, with good tolerability and a convenient dosing schedule."
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