-- Data Presented Today at DDW Demonstrate Linaclotide Provided Early Onset of Abdominal Pain Relief and Improved Bowel Habits --
CAMBRIDGE, Mass. and NEW YORK, May 31, 2009 /PRNewswire-FirstCall/ -- Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc. (NYSE: FRX) today announced results from additional analyses of their Phase 2b study assessing the safety and efficacy of the novel, first-in-class agent linaclotide in 419 patients with irritable bowel syndrome with constipation (IBS-C). Previous analyses of these data indicated that once-daily oral dosing with linaclotide, across a range of doses, significantly improved abdominal symptoms, bowel habits, and global assessments over the 12-week treatment period. These additional analyses demonstrated that patients treated with linaclotide experienced a statistically significant improvement in abdominal symptoms, bowel habits, and global assessments within the first week of treatment. Results were presented today at the Digestive Disease Week (DDW) conference being held in Chicago from May 30 through June 4, 2009. The companies also will present additional data throughout the week from studies of linaclotide in patients with IBS-C or chronic constipation (CC).
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The data presented today in an oral presentation (Abstract 157: Effect of Linaclotide on 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.
