(PRWEB) July 26, 2002
TORONTO, Ontario, June 24 - Following the announcement of the United States Food and Drug Administration's (FDA) approval of Zelnorm tablets (tegaserod maleate), the first drug to receive FDA-approval for short-term treatment of women with irritable bowel syndrome (IBS) whose primary bowel symptom is constipation, Jeffrey Roberts, President and Founder of the Irritable Bowel Syndrome Self Help Group, and Founder of the Zelnorm Action Group, commented:
"Zelnorm is a much needed drug for women suffering from constipation predominant IBS. The IBS Self Help Group and Zelnorm Action Group are very grateful for the decision that the FDA has made in approval of this medicine. We have been working for the approval of this medicine based on the relief of symptoms of bloating, pain and constipation, that we have heard about, from women, while involved in the clinical trials and under compassionate use, of this medication."
Background on Zelnorm:
Zelnorm increases the movement of stools (fecal matter) through the bowels. Zelnorm does not cure IBS, nor does it treat diarrhea-predominant IBS. Zelnorm reduces pain and discomfort in the abdominal area, and reduces bloating and constipation.
FDA based its decision to approve Zelnorm on the results of three randomized, double-blind, placebo-controlled clinical studies each lasting 12 weeks.
During the studies, patients were asked each week to rate their overall well-being, symptoms of abdominal discomfort and pain, and altered bowel habits.
At the end of the third month of the studies, the proportion of patients responding favorably to Zelnorm was greater than the proportion of patients responding to placebo. The differences in response rates for Zelnorm vs. placebo were greater at month 1 than month 3 suggesting efficacy may decrease over time. The efficacy of Zelnorm beyond 12 weeks has not been studied.
About the Zelnorm Action Group:
The Zelnorm Action Group was organized by members of the IBS Self Help Group (http://www.ibsgroup.org) and members who had be involved in clinical trials for tegaserod maleate.
The Zelnorm Action Group (ZAG) was seeking access to the medicine Zelnorm (tegaserod maleate). ZAG ultimately seeks permanent access and safe distribution of the medicine to those diagnosed with IBS-Constipation.
The Zelnorm Action Group believes the medicine to be safe, if dispensed properly, and that the benefits of Zelnorm far outweigh the potential risk for adverse side affects.
About the Irritable Bowel Syndrome (IBS) Self Help Group:
The IBS Self Help Group is the premier internet self help health site about Irritable Bowel Syndrome, with more than 13,000 members.
The IBS Self Help Group (ibsgroup.org), formed in 1987, is in support of those who suffer from IBS, those who are looking for support for someone who has IBS, and medical professionals who want to learn more about IBS. The IBS website was launched in May 1995. The IBS Self Help Group website provides access to bulletin and chat boards, book list and store, medication listings, diagnosis and treatment, clinical study listings and support groups.
Irritable Bowel Syndrome (IBS) Self Help and Support Group
Jeffrey Roberts, President and Founder
Zelnorm Action Group