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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

CSBM/week and mean daily abdominal pain of at least mild severity. Treatment effects in the intent-to-treat population were estimated using an analysis of covariance and the Cochran-Mantel Haenszel test.

About Linaclotide

Linaclotide is a first-in-class compound in Phase 3 clinical development for the treatment of IBSC and CC. Linaclotide demonstrated proof of concept in a comprehensive Phase 2b program, comprised of two clinical studies in over 700 patients with either IBS-C or CC. In patients with IBS-C, linaclotide significantly reduced abdominal pain, discomfort, and bloating and improved bowel function throughout the 12-week treatment period. In patients with CC, linaclotide reduced constipation, abdominal discomfort, and bloating throughout the 4-week treatment period. Across both studies, the most common adverse event in the linaclotide-treated groups was diarrhea, and diarrhea was the most common adverse event leading to discontinuation. Linaclotide is a once daily, orally delivered peptide that acts locally in the gut with no detectable systemic exposure at therapeutic doses. Linaclotide is an agonist of guanylate cyclase type-C, a receptor found on the lining of the intestine. An issued composition of matter patent for linaclotide provides protection to 2025. In September 2007, Ironwood and Forest entered into a 50/50 collaboration to co-develop and co-promote linaclotide in the United States. In April 2009, Ironwood licensed to Almirall the European rights to develop and commercialize linaclotide.

About Irritable Bowel Syndrome with Constipation (IBS-C)

IBS-C is a chronic functional gastrointestinal disorder characterized by abdominal pain, discomfort, and bloating associated with altered bowel habits. There are currently few available therapies to treat this disorder. Nine million U.S. patients have been diagnosed with IBS-C, and as many as 15 million people in the U.S. suffer from it.
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SOURCE Forest Laboratories, Inc.; Ironwood Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
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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
7. Forest Laboratories, Inc. and Laboratorios Almirall, S.A. Provide an Update on the Aclidinium Bromide Clinical Development Program
8. Forest Laboratories, Inc. and Cypress Bioscience, Inc. Announce Positive Results of Phase III Study of Milnacipran for the Management of Fibromyalgia
9. Forest Laboratories, Inc. and Gedeon Richter Plc Announce Positive Phase II Results with the Investigational Antipsychotic Cariprazine in Patients with Acute Mania Associated with Bipolar I Disorder
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