# Abdominal Pain and Constipation Significantly Reduced by Zelnormï¿½ (tegaserod maleate)



## Jeffrey Roberts (Apr 15, 1987)

http://www.us.novartis.com/press_releases/..._990461043.html Abdominal Pain and Constipation Significantly Reduced by Zelnormï¿½ (tegaserod maleate) in Women with Irritable Bowel Syndrome Atlanta, GA, May 21, 2001 ï¿½ Two-Thirds of Female Patients Experienced Rapid and Sustained Relief Zelnormï¿½ (tegaserod maleate) demonstrated significant improvement of multiple symptoms in female patients with irritable bowel syndrome (IBS) suffering from abdominal pain, discomfort and constipation, according to a new study. These data, from a study of more than 1,500 female patients, were presented at the 32nd annual Digestive Disease Week (DDW) meeting. Zelnorm currently is under Food and Drug Administration (FDA) review for the treatment of abdominal pain, discomfort and constipation in female patients with C-IBS. ï¿½One of the true unmet needs in medicine today is a safe and effective treatment for IBS, a disease that affects about one-in-five Americans,ï¿½ said Brian Lacy, MD, assistant professor of Medicine in the Division of Digestive Diseases at Johns Hopkins Bayview Medical Center and acting director of the Marvin M. Schuster Center for Digestive and Motility Disorders. ï¿½These findings suggest a major advance in treating IBS because the data demonstrate that the majority of patients treated with Zelnorm experienced relief within the first week of treatment.ï¿½ In this placebo-controlled, double-blind study, 1,519 female IBS patients were randomly assigned to either 12 mg daily of Zelnorm or placebo for 12 weeks, followed by a four-week withdrawal period. Within the first week, patients treated with Zelnorm experienced significant improvements (p<0.05) as measured by the Subjectï¿½s Global Assessment (SGA) of Relief, which evaluates abdominal pain and discomfort, constipation, and overall well being. Efficacy was maintained throughout the treatment period. Zelnorm also demonstrated significant improvements (p<0.05) in the three bowel-related assessments (stool frequency, stool consistency and straining) within the first week, and these improvements were sustained throughout the treatment period. The most common adverse events reported in this study included headache and diarrhea. In most cases, the diarrhea occurred early, was transient, and was most often observed as a single episode during the 12-week treatment period. In this study, discontinuations due to adverse events occurred in 6.4% (Zelnorm) and 4.7% (placebo) patients. Discontinuations due to diarrhea were 1.6% (Zelnorm) and 0% (placebo). DDW is a joint meeting of the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterology Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT). IBS is a chronic disorder characterized by abdominal pain, discomfort, and constipation or diarrhea (or an alternating pattern of the two). This disorder has been recognized as the second leading cause of workplace absenteeism in the U. S. after the common cold. This release contains certain ï¿½forward-looking statements,ï¿½ relating to the Companyï¿½s business, which can be identified by the use of forward-looking terminology such as ï¿½significantly,ï¿½ ï¿½experience,ï¿½ ï¿½demonstrate,ï¿½ ï¿½under review,ï¿½ ï¿½unmet,ï¿½ ï¿½advance,ï¿½ ï¿½suggest,ï¿½ or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the potential benefit of Zelnorm as evidenced by the results of clinical studies. Those statements reflect the current views of the Company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the Company and Zelnorm to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. There are no guarantees that the aforementioned studies will result in the commercialization of Zelnorm in any market. Any such commercialization can be affected by, among other things, additional analysis of data, new data, uncertainties relating to product development, regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection, competition in general, and other risks and factors referred to in the Companyï¿½s current Form 20-F on file with the Securities and Exchange Commission of the United States. Should one or more of these risks or uncertainties materialize, or should underslying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Bristol-Myers Squibb Company is an $18 billion diversified, global health and personal care company whose mission is to extend and enhance human life. Visit Bristol-Myers Squibb on the world wide web at http://www.bms.com.[/URL] Novartis Pharmaceuticals Corporation, located in East Hanover, NJ is an affiliate of Novartis AG (NYSE: NVS), a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 2000, the Group's ongoing businesses achieved sales of CHF 29.1 billion (USD 17.2 billion) and invested approximately CHF 4.0 billion (USD 2.4 billion) in R&D. Headquartered in Basel, Switzerland, Novartis employs about 67 600 people and operates in over 140 countries around the world. For further information please consult http://www.novartis.com.[/URL] # # #Media, please contact:Kate King of Novartis -- Office: 973-781-5588; Mobile: 646-456-0293Marian Cutler of Novartis -- Office: 973-781-5970; Mobile: 917-751-4756Tracy Furey of Bristol-Myers Squibb -- Office: 609-252-3208Trina Chiara of Ruder Finn, 860-673-4017Investors Only, please contact:Kamran Tavangar, Novartis Corporation ï¿½ 212-830-2433


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## Guest (May 23, 2001)

Does anyone know if this drug is just for women or does it work for men too? I'm curious to know.


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