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A 1 FDA Advisory Committee for Zelnorm Jeffrey D. Roberts, B.Sc. President & Founder Irritable Bowel Syndrome Self Help Group, Irritable Bowel Syndrome.

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Presentation on theme: "A 1 FDA Advisory Committee for Zelnorm Jeffrey D. Roberts, B.Sc. President & Founder Irritable Bowel Syndrome Self Help Group, Irritable Bowel Syndrome."— Presentation transcript:

1 A 1 FDA Advisory Committee for Zelnorm Jeffrey D. Roberts, B.Sc. President & Founder Irritable Bowel Syndrome Self Help Group, Irritable Bowel Syndrome Association, Irritable Bowel Syndrome Association, Founder Zelnorm Action Group

2 A 2 Prevalence of Chronic Constipation Chronic Constipation 2-28% Functional Disorders References: References: Definitions, Epidemiology, and Impact of Chronic Constipation, Nicholas J. Talley, MD, PhD, FRACP, Vol. 4 Suppl Reviews In Gastroenterological Disorders

3 A 3 How does a Chronic Constipated sufferer feel? UnwellUnwell AloneAlone WorriedWorried FrustratedFrustrated DesperateDesperate HelplessHelpless Poor quality of lifePoor quality of life

4 A 4 What are the symptoms? May not have a bowel movement for up to 21 daysMay not have a bowel movement for up to 21 days Pass hard stoolsPass hard stools Lack the ability to defecate on demandLack the ability to defecate on demand Strain at every bowel movementStrain at every bowel movement

5 A 5 Quality of Life with Zelnorm Better83% No Change 17% References: Electronic survey conducted by the Irritable Bowel Syndrome Self Help Group June 2004 – July 2004 of some current Zelnorm users. Patients’ Perspective

6 A 6 Diarrhea16% Patients’ Perspective Side Effects while taking Zelnorm References: Electronic survey conducted by the Irritable Bowel Syndrome Self Help Group June 2004 – July 2004 of some current Zelnorm users. None79% Diarrhea16% Nothing Significant 79% Rectal Bleeding 5% Ischemic Colitis 0%

7 A 7 Conclusion Chronic constipation sufferer’s quality of life is dramatically improved with access to Zelnorm.Chronic constipation sufferer’s quality of life is dramatically improved with access to Zelnorm. Adverse events should not deter either the pharmaceutical or the FDA from maintaining the drugs availability.Adverse events should not deter either the pharmaceutical or the FDA from maintaining the drugs availability. The medical community must be informed through an additional indication that Zelnorm is an effective treatment for chronic constipation.The medical community must be informed through an additional indication that Zelnorm is an effective treatment for chronic constipation.


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