Study Reveals Zelnorm(R) May Be A Safe And Effective Treatment For Additional Group Of IBS Patients With A Mixed Bowel Pattern

Main Category: Irritable-Bowel Syndrome
Also Included In: GastroIntestinal / Gastroenterology
Article Date: 23 May 2006 - 0:00 PDT

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Novartis today announced study results showing promise for Zelnorm(R) (tegaserod maleate) as a safe and efficacious medical treatment for patients with Irritable Bowel Syndrome with a mixed bowel pattern (IBS-M). This is the first study to identify a potential treatment option for patients who suffer from IBS-M. The findings were presented at Digestive Disease Week 2006.

IBS is a dysmotility and sensory disorder characterized by abdominal pain or discomfort, bloating, and altered bowel function. Based on Rome II criteria, IBS patients are classified based on their primary bowel complaint as either IBS with Constipation (IBS-C) or IBS with Diarrhea (IBS-D). Those IBS sufferers who do not fulfill scientifically based standards for either IBS-C or IBS-D can exhibit a mixed bowel pattern, or IBS-Mixed (IBS-M). A recent study of IBS sufferers published in Gastroenterology revealed that nearly one third of participants experienced IBS-M.(1)

"IBS patients who suffer with a mixed bowel pattern are in need of an effective treatment option," said William Chey, M.D., Associate Professor of Medicine and Director of the GI Physiology Laboratory at the University of Michigan Health System. "These study results are promising as Zelnorm was shown to provide a statistically significant improvement in satisfactory relief of IBS symptoms in both the IBS-C and IBS-M groups. More than 50 percent of the IBS-M patients experienced a response to tegaserod."

Zelnorm is the first and only prescription medication approved by the U.S. Food and Drug Administration (FDA) for both Chronic Idiopathic Constipation and IBS with Constipation.

"IBS affects millions of Americans. We are encouraged to see that in addition to providing relief to millions of IBS with Constipation and Chronic Constipation sufferers, Zelnorm may now offer hope to IBS patients with a mixed bowel pattern," said Marielle Cohard-Radice, Executive Director, Gastroenterology, Clinical Development & Medical Affairs, Novartis Pharmaceuticals Corporation.

IBS-M Study Results

The study was designed to determine whether Zelnorm was safe and effective for the treatment of IBS-M. At present, no medical therapy has been demonstrated to be effective in IBS-M patients.

The randomized, double-blind, placebo-controlled, multicenter study evaluated 661 women with IBS-C (337) or IBS-M (324). Study participants were asked to provide an assessment of satisfactory relief over four weeks of treatment with Zelnorm 6 mg b.i.d. or placebo. Also assessed, were the proportion of patients reporting satisfactory relief for greater than or equal to 3 out of 4 treatment weeks (75% rule) and improvement during each of the 4 weeks in individual IBS symptoms. Baseline symptom assessment clearly distinguished between IBS-C and IBS-M cohorts.

Overall, Zelnorm provided statistically significant improvement in satisfactory relief of IBS symptoms over a four-week treatment for the IBS-C and IBS-M cohorts. In the two cohorts, the percentage of patients experiencing satisfactory relief of IBS symptoms (75% rule) was significantly higher for Zelnorm compared to placebo (IBS-C: 43.3% vs 28.9%, p=0.008 and IBS-M: 52.3% vs 36.3%, p=0.010). Zelnorm was significantly superior to placebo at improving weekly bowel movement frequency, stool consistency and straining.

The most frequent adverse events were diarrhea (Z 9.4% and P 2.1%), headache (Z 5.5% and P 6.6%), abdominal pain (Z 3% and P 2.1%), and nausea (Z 2.1% and P 3.3%). Adverse event discontinuations were low for both Zelnorm and placebo groups (IBS-C: 1.2% vs 2.4% and IBS-M: 2.5% vs. 3.6%). Diarrhea was reported more frequently in the IBS-M population (Z 12.1% and P 1.8%) compared to with the IBS-C (Z 7% and P 2.4%) subset. However discontinuations due to diarrhea were low in both subsets (1.5% for IBS-M and 0.6% for IBS-C). Diarrhea with Zelnorm typically occurred soon after initiating therapy and lasted 2-3 days without recurrence. There were no cases of diarrhea with clinically significant consequences (i.e., hospitalization, need for IV fluids, abnormal lab values).

About Zelnorm

Zelnorm is indicated for the treatment of men and women less than 65 years of age with Chronic Idiopathic Constipation. The effectiveness of Zelnorm in patients 65 years or older with Chronic Idiopathic Constipation has not been established. Zelnorm is also indicated for the short-term treatment of women with IBS whose primary symptom is Constipation. The safety and effectiveness of Zelnorm in men with IBS with Constipation have not been established. Efficacy beyond 12 weeks has not been studied. Zelnorm is the first in a novel class of drugs that act as an agonist at 5HT4 (serotonin type 4) receptors. Zelnorm mimics the natural effects of serotonin by activating 5HT4 receptors, which normalizes impaired motility in the GI tract, inhibits visceral sensitivity and stimulates intestinal secretion. Overall, safety data is now available in more than 14,000 patients who have enrolled in clinical trials assessing Zelnorm's safety and efficacy in various GI conditions.

Serious consequences of diarrhea, including hypovolemia, hypotension, and syncope, have been reported with Zelnorm. Zelnorm should be discontinued immediately in patients who develop severe diarrhea, hypotension, or syncope. Zelnorm should not be initiated in patients who are currently experiencing or frequently experience diarrhea.

Zelnorm should be discontinued immediately in patients with new or sudden worsening of abdominal pain. Ischemic colitis and other forms of intestinal ischemia have been reported in patients receiving Zelnorm during marketed use of the drug. In some cases, hospitalization was required. Patients who develop symptoms of ischemic colitis such as rectal bleeding, bloody diarrhea, or new or worsening abdominal pain should discontinue therapy immediately and be evaluated. Zelnorm should not be resumed if ischemic colitis or other forms of intestinal ischemia are diagnosed. A causal relationship between Zelnorm and these events has not been established. They only adverse events reported significantly more often with Zelnorm than with placebo were diarrhea (7% vs. 3%) in Chronic Constipation studies, and headache (15% vs. 12%) and diarrhea (9% vs. 4%) in IBS with Constipation studies.

Zelnorm was developed by Novartis and is also known in some countries as Zelmac. Approximately 3 million patients worldwide have been treated with Zelnorm to date. It is approved in more than 56 countries for IBS with Constipation. Zelnorm also is approved for use in Chronic Constipation in more than 20 countries, including Mexico and many of the Latin American countries.

About DDW

Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place Sunday, May 21 through Thursday, May 25 in Los Angeles, CA. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology.

Forward-Looking Statement

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 "may," "showing promise," "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, future clinical trial results related to dyspepsia, GERD and other medical conditions, 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 Novartis

Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, gastrointestinal and respiratory areas. The company's mission is to improve people's lives by pioneering novel healthcare solutions.

Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG (NYSE: NVS) - a world leader in offering medicines to protect health, treat disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. Novartis is the only company with leadership positions in both patented and generic pharmaceuticals. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics and leading self-medication OTC brands. In 2005, the Group's businesses achieved net sales of USD 32.2 billion and net income of USD 6.1 billion. Approximately USD 4.8 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 91,000 people and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.

(1) A Prospective Assessment of Bowel Habit in Irritable Bowel Syndrome in Women: De.ning an Alternator. Drossman, et. al. Gastroenterology

Novartis Pharmaceuticals Corporation
http://www.novartis.com

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