# American College of Gastroenterology Gives Zelnorm 'Grade A' Recommendation



## Jeffrey Roberts (Apr 15, 1987)

New Data Demonstrate Zelnorm(tm) (tegaserod maleate) Effectiveness and Safety for The Multiple Symptoms of Abdominal Pain and Discomfort, Bloating, and Constipation Associated with Irritable Bowel SyndromeTuesday October 22, 10:59 am ET American College of Gastroenterology Gives Zelnorm 'Grade A' Recommendation EAST HANOVER, N.J., Oct. 22 /PRNewswire-FirstCall/ -- New data published in Alimentary Pharmacology & Therapeutics demonstrate Zelnorm (tegaserod maleate) provides rapid relief for women suffering from the multiple symptoms of abdominal pain and discomfort, bloating and constipation associated with irritable bowel syndrome (IBS). An additional study in the same journal found Zelnorm to be safe and well tolerated over a 12-month period. A third study published in The American Journal of Gastroenterology, shows that Zelnorm did not adversely affect cardiac function in more than 2,500 patients. These new findings further demonstrate the efficacy and safety of Zelnorm and its significant role in the short-term treatment of women with IBS whose primary bowel symptom is constipation. In addition, today at the 67th annual meeting of the American College of Gastroenterology (ACG), the ACG Functional Gastrointestinal Disorders Task Force released a position statement on the management of IBS. In its consensus opinion, tegaserod received the only "Grade A" recommendation for the treatment of IBS with constipation, supported by the strongest level of clinical evidence."The position statement was developed to assist physicians with diagnosing and treating patients with IBS," said Lawrence J. Brandt, MD, Chairman of the ACG Functional Gastrointestinal Disorders Task Force. "The ACG Task Force 'Grade A' recommendation for tegaserod for the treatment of the multiple symptoms of abdominal pain and discomfort, bloating and constipation is based on a comprehensive review of tegaserod clinical data, which shows tegaserod is more effective than placebo at relieving global IBS symptoms in female IBS with constipation patients."Zelnorm Efficacy & Safety Over Three MonthsAccording to the study published in the November issue of Alimentary Pharmacology & Therapeutics (Vol. 16, No. 11), Zelnorm provided multiple symptom relief of the abdominal pain and discomfort, bloating, and constipation of IBS compared to placebo (p<0.05), as measured by the Subject's Global Assessment of Relief (SGA). The SGA is a measurement tool which takes into account overall well being, symptoms of abdominal pain and discomfort, and constipation. Symptom improvements were seen by the first week of Zelnorm treatment, and persisted throughout the 12-week treatment period. In addition, Zelnorm was shown to provide relief of the individual symptoms of abdominal pain and discomfort, bloating and constipation.In this prospective, randomized, double-blind, placebo-controlled study, 1,519 female IBS patients at 131 centers in the United States received either Zelnorm 6 mg b.i.d. (n=767), or placebo (n=752) for 12 weeks. The treatment period was preceded by a four-week baseline period without treatment, and followed by a four-week open label withdrawal period. IBS symptoms returned within the first week after withdrawal of therapy. The only adverse event reported significantly more often with Zelnorm than placebo was mild and transient diarrhea (6.4% Zelnorm, 2.9% placebo).Zelnorm Long-term SafetyIn a 12-month study published in the October issue of Alimentary Pharmacology & Therapeutic (Vol. 16, No. 10), Zelnorm was shown to be safe over a 12-month period. A total of 579 patients with the multiple symptoms of abdominal pain and discomfort, bloating and constipation associated with IBS were enrolled in this long-term open label international study. The most common adverse event reported as possibly related to Zelnorm was mild and transient diarrhea (10.1%).Cardiac Safety StudyIn a separate study, published in the September issue of the American Journal of Gastroenterology (Vol. 97, Issue 9), over 11,500 electrocardiographic (ECG) tracings were evaluated and Zelnorm was not associated with changes in ECG intervals. The analysis, which pooled data from three randomized, double-blind, placebo-controlled, parallel group clinical studies, consisted of 1,679 IBS patients with symptoms of abdominal pain and constipation who were treated with Zelnorm twice a day for 12 weeks, compared with 837 patients who received placebo. Electrocardiograms were recorded at baseline on day one and week four and 12 of treatment.About IBSIBS is characterized by abdominal pain or discomfort, bloating, and altered bowel function (constipation and/or diarrhea). IBS affects up to one in five Americans and is a leading cause of workplace absenteeism, second only to the common cold. IBS costs the U.S. healthcare system up to an estimated $30 billion annually in direct and indirect costs.About ZelnormThe U.S. Food and Drug Administration approved Zelnorm for the short-term treatment of women with IBS whose primary bowel symptom is constipation. The safety and effectiveness of Zelnorm in men has not been established. Zelnorm is the first agent in a new class of drugs called serotonin-4 receptor 5HT4 agonists developed to target the GI tract. By activating 5HT4 receptors, Zelnorm normalizes impaired motility throughout the GI tract, stimulates intestinal secretion and inhibits visceral sensitivity. Zelnorm is the first agent proven to provide relief of the abdominal pain and discomfort, bloating and constipation of IBS. The recommended dosage of Zelnorm is 6 mg taken orally twice daily before meals for four to six weeks.Zelnorm was discovered and developed by Novartis. Zelnorm, known internationally as Zelmac, is approved in more than 35 countries including Australia, Switzerland, Canada, and Brazil. Zelnorm is being studied as a potential treatment for other important gastrointestinal disorders such as chronic constipation, gastroesophageal reflux disease (GERD) and functional dyspepsia. It is the tenth Novartis product to receive FDA approval since January 2000.In clinical studies, Zelnorm was generally well tolerated. The side effects that occurred significantly more often with Zelnorm than with placebo were headache (15% vs 12%) and diarrhea (9% vs 4%). Zelnorm is contraindicated for patients with severe renal impairment, moderate or severe hepatic impairment, a history of bowel obstruction, symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, abdominal adhesions or those with a known hypersensitivity to the drug or any of its excipients. Zelnorm should not be initiated in patients who are currently experiencing or frequently experience diarrhea.This release contains certain forward-looking statements relating to the Company's business, which can be identified by the use of forward-looking terminology such as "provides," "shows," "was shown to be," "found," "potential," or similar expressions, or by discussions of strategy, plans or intentions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Zelnorm to be materially different from any future results, performance or achievements expressed or implied by such statements. Specifically, there are no guarantees that the data described above will result in the commercial success of Zelnorm. Any such success can be affected by, among other things, uncertainties relating to product development, adverse regulatory actions or delays, 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 Company's current Form 20-F on file with the Securities and Exchange Commission of the United States.About NovartisLocated in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG (NYSE: NVS - News), a world leader in pharmaceuticals and consumer health. In 2001, the Novartis Group's businesses achieved sales of CHF 32.0 billion (USD 19.1 billion) and a net income of CHF 7.0 billion (USD 4.2 billion). The Group invested approximately CHF 4.2 billion (USD 2.5 billion) in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 74,000 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com . Contact: Carrie Urbas Novartis Pharmaceuticals Corp. (973) 781-7065 carrie.urbas###pharma.novartis.com John McInerney Ruder Finn (212) 593-6348 mcinerneyj###ruderfinn.com


----------



## trbell (Nov 1, 2000)

it's still not clear to me but it sounds like tegasrod provides occasional relief of symptoms for women.tom


----------

