Eluxadoline: Phase III data

Top-line data from the double-blind, international Phase III Study 3002 in 1,146 patients with IBS-D showed that twice-daily 75 and 100 mg oral eluxadoline each met the FDA-defined primary endpoint of improving a composite responder rate from baseline to week 12 vs. placebo (28.9% and 29.5%, respectively, vs. 16.2%, p<0.001 for both). Low- and high-dose eluxadoline also met the EMA-defined primary endpoint of improving a composite responder rate from baseline to week 26 vs. placebo (30.4% and 32.6% respectively, vs. 20.2%, p<=0.001 for both). Responders were defined as patients who achieved a Bristol Stool score of <5 points or the absence of a bowel movement and a >=30% improvement in worst abdominal pain scores in the past 24 hours compared to baseline on >=50% of days.

On the individual secondary components of the FDA-defined endpoint, low- and high-dose eluxadoline significantly improved stool consistency response rates (37% and 35.5%, respectively, vs. 20.9%, p<0.001 for both) and high-dose eluxadoline non-significantly improved pain response rate (50.9% vs. 45.3%, p=0.12) from baseline to week 12 vs. placebo. The most common reported adverse events were constipation and nausea. Additionally, sporadic liver enzyme elevations of >3 times the upper limit of normal were observed in both treatment arms, all of which resolved. Next quarter, Furiex plans to submit an NDA to FDA for eluxadoline to treat IBS-D. The company plans to conduct a pediatric trial with the compound before filing in the EU, where a submission is slated for 1Q15. ...