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Ironwood and Forest Present Additional Positive Phase 2b Study Results for Linaclotide in Patients With Irritable Bowel Syndrome With Constipation
Date:5/31/2009

n IBS-C Symptoms in the First Week of Treatment: Results from a Phase 2b Study) by investigator Anthony Lembo, M.D., Director, GI Motility Center, Beth Israel Deaconess Medical Center, Boston, indicated that within the first week of treatment, linaclotide significantly improved abdominal symptoms, bowel habits, and global assessments. A statistically significant percentage of patients (48 to 64 percent) experienced a clinically meaningful reduction (greater than or equal to 0.5 on a five-point severity scale) in abdominal pain, abdominal discomfort, and bloating in the first week of treatment, compared with 25 to 37 percent of placebo patients (p<0.05 for each pairwise comparison of a linaclotide dose group to the placebo group). For patients receiving the Phase 3 linaclotide dose, 300 ug daily, 60 percent showed this level of improvement in the first week (p<0.005). There was also significant improvement in stool frequency, stool consistency, straining, adequate relief, and global relief during the first week of linaclotide treatment (p<0.05 for all dose groups and p<0.001 for the 300 ug dose group). These levels of improvement were sustained throughout the 12 weeks of treatment. Linaclotide was well tolerated at all doses with no treatment-related serious adverse events. The most common adverse event was diarrhea; however, there were no associated dehydration or electrolyte abnormalities. Study discontinuations due to diarrhea ranged from 1 to 7 percent of patients in the four linaclotide dose groups; no placebo?treated patients discontinued due to diarrhea.

"Management of abdominal pain, discomfort, and bloating, in addition to constipation, is important for patients suffering from IBS-C because these symptoms can be debilitating," said Anthony Lembo, M.D. "The results of this Phase 2b study suggest treatment with linaclotide may reduce symptoms in patients within a week of starting treatment."

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SOURCE Forest Laboratories, Inc.; Ironwood Pharmaceuticals, Inc.
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Related medicine technology :

1. Ironwood Announces Linaclotide European Licensing Agreement with Almirall
2. Ironwood and Forest Present Positive Phase 2b Study Results for Linaclotide in Patients With Irritable Bowel Syndrome With Constipation
3. Ironwood and Collaborators Present Preclinical Data Demonstrating That Cyclic GMP Alleviates Intestinal Pain
4. Ironwood Raises $50 Million to Advance Linaclotide Through Phase 3
5. Ironwood and Forest to Present Positive Data From Linaclotide Phase 2b IBS-C Study at ACG Annual Scientific Conference
6. Ironwood Pharmaceuticals and Forest Laboratories Announce Presentation of Linaclotide Phase 2b Chronic Constipation Study Results
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