# Zelnorm is approved in the United States



## Jeffrey Roberts (Apr 15, 1987)

http://www.prnewswire.com/cgi-bin/stories....2002/0001770559 Wednesday July 24, 10:42 am Eastern TimePress ReleaseSOURCE: Novartis Pharmaceuticals CorporationFDA Approves Zelnorm, A Novel Treatment for Irritable Bowel Syndrome in Women With ConstipationZelnorm is First and Only Prescription Therapy for the Relief of the Common Symptoms of Abdominal Pain and Discomfort, Bloating, and Constipation in Women with IBSEAST HANOVER, N.J., July 24 /PRNewswire-FirstCall/ -- (NYSE: NVS - News) - The Novartis drug Zelnorm(tm) (tegaserod maleate)* today became the first and only prescription medication approved by the U.S. Food and Drug Administration (FDA) for the short-term treatment of women with irritable bowel syndrome (IBS) whose primary bowel symptom is constipation. Until now, no prescription medication has been approved in the United States to treat the multiple symptoms of abdominal pain and discomfort, bloating, and constipation associated with IBS. The medical community has recognized that therapies traditionally used to treat these symptoms have been generally ineffective or poorly tolerated.(Photo: http://www.newscom.com/cgi-bin/prnh/20020724/NYW093 )"Zelnorm marks a breakthrough for the millions of women who have suffered for years with IBS with constipation waiting for a safe and effective therapy to relieve their symptoms," said Daniel Vasella, MD, Chairman and CEO, Novartis AG. "As with our discoveries in oncology, heart disease and transplantation, Zelnorm reflects our commitment to bring innovative treatments to patients with significant unmet needs. We will rapidly make Zelnorm available to patients, and plan for an early fall market introduction."About IBSIBS is characterized by abdominal pain and discomfort, bloating, and altered bowel function (constipation and/or diarrhea). IBS affects up to one in five Americans. Second only to the common cold as a leading cause of workplace absenteeism in the U.S., IBS costs the U.S. healthcare system up to an estimated $30 billion annually in direct and indirect costs."Patients suffering from abdominal pain, bloating, and constipation associated with IBS endure a great deal of distress, often preventing them from participating in such simple everyday activities as going to work or school, participating in sports, or enjoying a vacation with their family," said Nancy Norton, President and Founder of the International Foundation for Functional Gastrointestinal Disorders. "The approval of Zelnorm is very exciting news for millions of women who suffer from this condition."Until recently, the cause of IBS has been poorly understood and under appreciated. However, in recent years, new research has yielded a better understanding of IBS and its causes. People who have abdominal pain and discomfort, bloating and constipation associated with IBS have a lower GI tract that may be more sensitive and work more slowly than it should. This may be due to the way their lower GI tract reacts to changes in a naturally occurring chemical in their body that regulates motility and the perception of pain and discomfort.About ZelnormZelnorm is the first agent in a new class of drugs called serotonin-4 receptor agonists (5HT4 agonist) developed to target the GI tract. By activating 5HT4 receptors, Zelnorm stimulates the peristaltic reflex and normalizes impaired motility in the GI tract. Zelnorm is the first agent proven to provide relief of the abdominal pain and discomfort, bloating and constipation of IBS."IBS with constipation is a very real medical disorder that has frustrated patients and physicians due to the obvious lack of safe and effective prescription medications to treat the painful symptoms," said Walter L. Peterson, MD, University of Texas, Southwestern School of Medicine in Dallas. "Zelnorm is an important advancement in IBS therapy. We can now provide safe and effective symptom relief to a significant number of patients for whom this was not possible before."The FDA approval of Zelnorm is based on clinical trials that show Zelnorm provides relief of the abdominal pain and discomfort, bloating and constipation in women with IBS.Three multicenter, double-blind, placebo-controlled studies involved 2,470 women with at least a three-month history of IBS symptoms prior to the study baseline period. Patients received either Zelnorm 6 mg/b.i.d. or placebo over a three-month period.Each week, participants rated their responses to the "Subject's Global Assessment of Relief," a measurement tool which takes into account overall well-being, symptoms of abdominal pain and discomfort, and constipation. Based on this assessment, more patients on Zelnorm experienced relief than patients on placebo. In addition, Zelnorm was shown to provide relief of the individual symptoms of abdominal pain and discomfort, bloating, and constipation.In clinical studies, Zelnorm was generally well tolerated. Side effects that occurred more often with Zelnorm than with placebo were headache (15% vs. 12%) and diarrhea (9% vs. 4%). The majority of the Zelnorm patients reporting diarrhea had a single episode. In most cases, diarrhea occurred within the first week of treatment. Typically, diarrhea resolved with continued therapy. Zelnorm is not indicated for patients who are currently experiencing or frequently experience diarrhea. The safety and effectiveness of Zelnorm in men have not been established.Zelnorm was discovered and developed by Novartis. Zelnorm, known internationally as Zelmac, is approved in more than 30 countries including Australia, Switzerland, Canada, and Brazil. Novartis also is conducting clinical assessments of Zelnorm as a potential treatment for other important gastrointestinal disorders such as chronic constipation and functional dyspepsia. It is the tenth Novartis product to receive FDA approval since January 2000.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 "until now," "innovative," and "first" 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. Some of these are uncertainties relating to unexpected regulatory delays, further clinical trial results regarding efficacy or safety of Zelnorm, government regulation or competition in general, as well as factors discussed in the Company's Form 20F filed with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.About NovartisLocated in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG (NYSE: NVS - News), a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal 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 71,000 people and operates in over 140 countries around the world. For further information please consult http://www.novartis.com. In the U.S., Canada, and South Africa: Zelnorm(tm) (tegaserod maleate); all other countries: Zelmacï¿½ (tegaserod) CONTACT: U.S. Media, Laura Hortas Novartis Pharmaceuticals Corp., (973) 781-7845 laura.hortas###pharma.novartis.com International Media Novartis Basel Press Office, +011-41-61-324-2200 Jessica Colon 908-277-5489 Michael Szumera Ruder Finn (212) 593-6393 szumeram###ruderfinn.com Philippa Jones Ruder Finn (212) 593-5818 jonesp###ruderfinn.com


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## TheDude0306 (Mar 10, 2001)

I saw the good news in the Star-Leger newspaper here in New Jersey. They also mention this website and the webmaster.I have 1 concern. Why does it say for women? I have had IBS-C for 13 years, I know I have IBS, after seeing a million doctors.Will I still be able to get it even though I am a man?


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