Furiex Pharmaceuticals (Nasdaq: FURX) has announced top-line results from two pivotal Phase III clinical trials evaluating the efficacy and safety of eluxadoline in the treatment of diarrhea-predominant irritable bowel syndrome (IBS-d).
The news more than doubled the company’s share price in its best day of trading. Furiex surged to close at $105.69 in New York yesterday, its highest value since its shares began trading in June 2010.
The trials met both the US Food and Drug Administration and the European Medicines Agency formally agreed-upon primary endpoints of composite response based on simultaneous improvements in stool consistency and abdominal pain. These endpoints are aligned with both the current FDA guidance and the 2013 EMA draft guidance for clinical trial evaluation of new medicines for irritable bowel syndrome.
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