# Novartis Pharmaceuticals Confirms the Safety and Efficacy of Zelmac



## Jeffrey Roberts (Apr 15, 1987)

Novartis Pharmaceuticals Confirms the Safety and Efficacy of Zelmacï¿½ (tegaserod maleate)Company Responds to Claims Raised by Public CitizenEAST HANOVER, NJ, March 22 - Novartis Pharmaceuticals Corporation confirmed today the efficacy and safety of Zelmacï¿½ (tegaserod maleate), which is under Food and Drug Administration (FDA) review for the treatment of abdominal pain, discomfort and constipation in female patients with irritable bowel syndrome (C-IBS). The approval of Zelmac is anticipated in the first half 2001. Public health and the safety of our products is of utmost importance to Novartis. Clinical data from more than 4,500 patients demonstrate the safety and efficacy of Zelmac. Last year, Novartis shared extensive data with the FDA public advisory committee, demonstrating no increased risk of ovarian cysts with Zelmac compared to placebo. Subsequently, Novartis provided FDA with an additional study of 1,500 female patients, with no reports of ovarian cysts in the drug-treated group. In a pooled analysis of controlled, double-blind studies submitted to FDA in December, there is no difference in the drug-treated group versus placebo, with regard to the incidence of ovarian cysts (0.12% placebo vs. 0.13% tegaserod). In addition, an expert panel has reviewed animal study data in rats and has concluded that there is no treatment-related increase in the incidence of ovarian cysts. As discussed at the advisory committee meeting, five patients were hospitalized,three were found not to have ovarian cysts and the remaining two were known to have a history of ovarian cysts prior to entry into the study."Claims regarding a link between Zelmac and ovarian cysts are without merit," said Sam Sue, MD, Vice President, Gastroenterology Research and Development. "There is no treatment-related link to ovarian cysts in human clinical trials or long-term animal studies. In fact, the prevalence of cysts found in the clinical trials is consistent with what is found in the general population." In clinical trials, Zelmac was shown to significantly reduce abdominal pain, bloating and constipation in patients with IBS, all of whom met internationally-recognized diagnostic criteria. Furthermore, patients entering the clinical trials had IBS for an average duration of 14 years. Additionally, the new 1,500 patient study confirmed the efficacy and safety of Zelmac."Everyday I see patients who suffer and whose lives are significantly handicapped because of IBS," said Sidney Cohen, MD, director of research, Division of Gastroenterology and Hepatology, Thomas Jefferson University Hospital, Philadelphia. "This is a serious medical disorder for which there are currently no safe and effective medications available." Zelmac belongs to a new class of drug, with a unique mechanism of action, which differs from that of Lotronexï¿½ (alosetron hydrochloride). The serious adverse events observed with Lotronex - ischemic colitis and severe constipation - have not occurred with Zelmac. The most commonly reported side effects associated with Zelmac are headache and diarrhea. IBS is one of the most common gastrointestinal (GI) disorders, affecting up to 40 million American adults. It is a chronic condition characterized by abdominal pain and symptoms associated with irregular bowel function, such as constipation, diarrhea or alternating pattern between the two. To date, no medication has proven to be safe and effective in treating IBS patients who suffer from abdominal pain, bloating and constipation as their main symptoms. Novartis will continue to work closely with FDA to bring this important, safe and effective medication to the market. Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions in a variety of therapeutic areas including gastroenterology, central nervous system, organ transplantation, cardiology, dermatology, oncology, respiratory and arthritis. 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). Novartis is 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] # # #For more information, please contact Marian Cutler of Novartis, 973-781-5970.Lotronex is a registered trademark of Glaxo Group Limited.


----------



## Jeffrey Roberts (Apr 15, 1987)

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH GASTROINTESTINAL DRUGS ADVISORY COMMITTEE NDA 21-200, Zelmac (tegaserod) Novartis Pharmaceuticals Corporation Monday, June 26, 2000 8:30 a.m. Marriott Washington Center 9751 Washington Boulevard Gaithersburg, MarylandTranscript: http://www.fda.gov/ohrms/dockets/ac/00/tra...ipts/3627t1.rtf


----------

