Ironwood Pharma and Forest Labs (FRX) Announces Positive Top-Line Results for Linaclotide in Two Phase 3's
Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc. (NYSE: FRX) today announced positive top-line results from two Phase 3 clinical trials assessing the safety and efficacy of once-daily dosing of the investigational drug linaclotide in patients with chronic constipation. Analyses of the data indicate that in both multicenter, randomized, double-blind, placebo-controlled trials, statistical significance was achieved for the primary endpoint of 12-week complete spontaneous bowel movement (CSBM) overall responder at the two doses studied in each trial (133 mcg/day: p-values<=0.0012 and 266 mcg/day: p-values<0.0001). In both trials, statistical significance (p<0.01) was achieved for all prespecified secondary endpoints, which included measures of bloating, abdominal discomfort, and average weekly CSBMs.
Peter Hecht, Chief Executive Officer of Ironwood, said, "We are very pleased to observe how well the top-line results of these larger Phase 3 trials replicate the effect of linaclotide observed in our Phase 2b trial."
The doses of linaclotide referenced in previous public disclosures represented the total peptide content; however, moving forward the doses will be expressed as linaclotide content. The 150 and 300 mcg linaclotide referenced in prior public disclosures are equivalent to the 133 and 266 mcg linaclotide content referenced in this public disclosure and all public disclosures going forward.
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