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Positive Phase III Data Reported for IBS Drug Eluxadoline
Response rates significantly higher versus placebo (February 4)
Eluxadoline (Furiex Pharmaceuticals) has met the primary endpoint of a composite response based on simultaneous improvements in stool consistency and abdominal pain in two phase III trials of patients with diarrhea-predominant irritable bowel syndrome (IBS-D).
The two studies (3001 and 3002) were randomized, double-blind, placebo-controlled trials in which a total of 2,428 patients received eluxadoline 75 mg twice daily (BID), eluxadoline 100 mg 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 to 12.
In study 3001, patients receiving eluxadoline demonstrated significantly higher responder rates for the composite endpoint (the patients' response over weeks 1 to 12). The rates were 25.1% for eluxadoline 100 mg (P = 0.004), 23.9% for eluxadoline 75 mg (P = 0.014), and 17.1% for placebo.
In study 3002, patients receiving eluxadoline also demonstrated significantly higher responder rates for the composite endpoint. The rates were 29.5% for eluxadoline 100 mg, 28.9% for eluxadoline 75 mg, and 16.2% for placebo (P < 0.001 for both doses).
Source: Furiex Pharmaceuticals; February 4, 2014.