Furiex Reports Eluxadoline Results; Studies Meet FDA And EMA Primary Endpoints

(RTTNews) - Furiex Pharmaceuticals, Inc. (FURX) announced top-line results indicating the two pivotal Phase III clinical trials evaluating the efficacy and safety of eluxadoline in the treatment of diarrhea-predominant irritable bowel syndrome, or IBS-d, met both the U.S. FDA and the European Medicines Agency EMA formally agreed-upon primary endpoints of composite response based on simultaneous improvements in stool consistency and abdominal pain. The company said these endpoints are aligned with both the current FDA guidance and the 2013 EMA draft guidance for clinical trial evaluation of new medicines for irritable bowel syndrome.

The studies, known as 3001 and 3002, were randomized, double-blind, placebo-controlled studies in which patients received eluxadoline, 75 mg twice-daily, or BID, eluxadoline 100 mg BID or placebo BID. A total of 2,428 subjects were enrolled across the two studies. The company said, in addition to showing both rapid onset and durable efficacy of the primary endpoints, both pivotal studies demonstrated robust efficacy for the secondary endpoint of adequate relief of IBS symptoms.