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Ironwood Pharmaceuticals and Forest Laboratories Announce Presentation of Linaclotide Phase 2b Chronic Constipation Study Results
Date:5/20/2008

ency, stool consistency, straining, bloating, abdominal discomfort, and severity of constipation. Linaclotide was well tolerated at all doses with no treatment-related serious adverse events in any patient during the treatment period. The most common adverse event was diarrhea, which occurred in 5 percent (75 mcg), 9 percent (150 mcg), 5 percent (300 mcg), and 14 percent (600 mcg) of linaclotide-treated patients compared to 3 percent of placebo-treated patients. Diarrhea resulted in the discontinuation of 3 percent of linaclotide-treated patients and none of the placebo-treated patients.

"Chronic constipation is an uncomfortable condition that can adversely affect a patient's quality of life," said Anthony Lembo, M.D. "These Phase 2b data indicate that linaclotide has the potential to significantly improve the symptoms associated with CC."

This study is part of a larger Phase 2 program investigating the effect of linaclotide treatment on patients with CC and irritable bowel syndrome with constipation (IBS-C). Ironwood and Forest previously announced the top-line interim analysis from the IBS-C study. The companies intend to present the Phase 2B IBS-C study data at an appropriate scientific venue later this year. The companies plan to initiate Phase 3 trials in both IBS-C and CC patients in the second half of 2008.

CC Trial Design

The U.S.-based Phase 2b study was designed to assess the safety, efficacy, and dose response of linaclotide in patients with CC. The primary efficacy endpoint was the change in the overall mean weekly frequency of SBMs from the pre-treatment baseline through the four-week treatment period. Following a no-drug washout period of 14-17 days, patients (n = 310, with equal randomization across treatment groups) were randomized to receive placebo or linaclotide once-daily in the morning at doses of 75 mcg, 150 mcg, 300 mcg or 600 mcg for 28 days. Following completion of the four weeks of double-blind treatment, patient
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SOURCE Forest Laboratories, Inc.; Ironwood Pharmaceuticals
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