Furiex Pharmaceuticals announced top-line results for two Phase 3 clinical trials evaluating the efficacy and safety of eluxadoline in the treatment of diarrhea-predominant irritable bowel syndrome (IBS-d).
Studies 3001 and 3002, were randomized, double-blind, placebo-controlled studies in which patients (n=2428) received eluxadoline 75mg twice-daily, eluxadoline 100mg BID or placebo BID. The primary efficacy endpoint was a composite response evaluated over the initial 12 weeks of double-blind treatment. Response rates were compared based on patients who met the daily composite response criteria (improvement in pain and stool consistency) for at least 50% of the days from weeks 1–12.
In Study 3001, patients receiving eluxadoline demonstrated statistically significantly higher response rates for the primary composite endpoints. For the FDA composite endpoint (response over weeks 1–12), the responder rates were 25.1% for eluxadoline 100mg (P=0.004), 23.9% for eluxadoline 75mg (P=0.014) and 17.1% for placebo.
In Study 3002, patients receiving eluxadoline demonstrated statistically significantly higher responder rates for the composite primary endpoints. For the FDA composite endpoint (response over weeks 1–12), the responder rates were 29.5% for eluxadoline 100mg, 28.9% for eluxadoline 75mg and 16.2% for placebo (P<0.001 both doses).
Previously eluxadoline was granted Fast Track status by the FDA.
For more information call (919) 456-7800 or visit Furiex.com.