# Zelnorm approved for marketing in Canada and Brazil



## Jeffrey Roberts (Apr 15, 1987)

http://dominoext.novartis.com/NC/NCPRRE01....19?OpenDocument 03/19/2002--------------------------------------------------------------------------------.. Green lights for Novartis' new IBS therapy in Canada and BrazilBasel, 19 March 2002 ï¿½ Novartis announced today that Health Canada's Therapeutic Products Directorate has granted marketing authorization for Zelnorm (tegaserod)*, for the symptomatic treatment of irritable bowel syndrome (IBS) in women whose main symptoms are abdominal pain/discomfort and constipation. The company also announced that the Brazilian Regulatory Authority, ANVISA, has granted marketing authorisation for Zelmacï¿½ (tegaserod) for the treatment of abdominal pain/discomfort, bloating and constipation. "Zelnorm/Zelmac is the first medication clinically proven to offer relief from the multiple symptoms of IBS," said Thomas Ebeling, CEO, Novartis Pharma AG. "These positive decisions further support the promise of Zelnorm/Zelmac as a future treatment of choice for both physicians and patients."Canadian approvalThe prevalence of IBS in Canada ranges from 6ï¿½13.5%1,2, with two-thirds of sufferers being female.1 Zelnorm is the first single effective therapy available in Canada to treat the multiple symptoms of IBS, which include abdominal pain/discomfort, bloating and altered bowel function."There are very few treatment options for patients suffering from Irritable Bowel Syndrome," said Gervais Tougas, MD, Head of GI Services, St Joseph's Healthcare and Associate Professor of Medicine, McMaster University, Hamilton, Canada. "Tegaserod targets many of the symptoms that so far we have had difficulty treating, in particular pain, bloating and constipation. The approval of tegaserod in Canada represents an important new alternative for physicians treating this debilitating condition."Brazilian approvalThe prevalence of IBS in Brazil ranges from 8.7% - 17.0% with 58.6% of sufferers being female.3 In Brazil, Zelmac will be available to treat the multiple symptoms of IBS, which include abdominal pain/discomfort, bloating and altered bowel function."The approval of Zelmac in Brazil brings hope to the many patients suffering from the chronic, debilitating symptoms of IBS with predominance of constipation," said Carlos Fernando Francisconi, MD, FACG, Associate Professor in Internal Medicine, Department of Gastroenterology at Universidade Federal do Rio Grande do Sul and PUC Rio Grande do Sul, Chief of Gastroenterology Divison at Hospital das Clï¿½nicas de Porto Alegre. "I am optimistic that this product will significantly improve the quality of life of thousands of Brazilian women."About Zelnorm/ZelmacZelnorm/Zelmac is now approved in more than 20 countries to include Australia, Switzerland and several other Latin American countries. Novartis continues to work with the US Food and Drug Administration and the European Agency for the Evaluation of Medicinal Products to help bring the benefits of this important new therapy to patients in need.Clinical DataThe approvals of Zelnorm/Zelmac are based on clinical trials involving more than 4500 patients. Throughout the trials two-thirds of patients treated with Zelnorm experienced overall symptom relief, including improvements in abdominal pain/discomfort, bloating and constipation.4 The majority had relief within one week.5 The drug was well tolerated with an adverse event profile similar to that of placebo, with the exception of headache and diarrhea, which in most cases was mild and transient.6,7 Discontinuations based on adverse events were 6.4% for the Zelnorm-treated group compared with 4.6% for the placebo group in the final trial.4References:1. Thompson WG, et al. Functional GI disorders in Canada: first population-based survey using Rome II criteria with suggestions for improving the questionnaire. Dig Dis Sci 2002;47:225ï¿½235.2. Bentkover JD, et al. The economic burden of irritable bowel syndrome in Canada. Can J Gastroenterol 1999;13(Suppl A):89Aï¿½96A.3. Quilici F.A., Andrï¿½ S.B. Sï¿½ndrome do Intestino Irritï¿½vel ï¿½ Um consenso nacional. Lemos Editorial, Sao Paulo , Brazil, 2000.4. Mueller-Lissner S, et al. Tegaserod, a 5HT4 partial agonist, relieves symptoms in irritable bowel syndrome patients with abdominal pain, bloating and constipation. Aliment Pharmacol Ther 2001;16:1655ï¿½66.5. Integrated summary of efficacy. January 2000. Novartis, data on file.6. Lefkowitz M, et al. Tegaserod provides relief of symptoms in female patients with irritable bowel syndrome (IBS) suffering from abdominal pain and discomfort, bloating and constipation. (Abstr). Gastroenterology 2001;120:A104.7. Integrated summary of safety. December 2000. Novartis data on file.# # #*In the US and Canada Zelnorm will be the brand name for tegaserod; in all other countries Zelmac will be the brand name.


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## Rose (Mar 25, 1999)

Great news, Jeff. Hopefully the US won't be far behind. The rep from Novartis involved in the clinical trial I was in, said Novartis was hoping for FDA approval by late summer or early fall.


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## trbell (Nov 1, 2000)

I think at this point that if they don't get it out soon they're going to lose their edge on other meds.tom


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## rlo (Jun 3, 2001)

Wonderful!!! We can keep our fingers crossed that the FDA will follow the lead and get this approved now that Canada has done so.Take care.Renee'


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## trbell (Nov 1, 2000)

we can do more than keep our fingers crossed.tom


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## Jeffrey Roberts (Apr 15, 1987)

Zelnorm will be in the pharmacies in Canada beginning Monday June 10.It will be sold as 6mg. tablets in a blister pack. The recommended dosage is 2 x 6mg. per day.It will be available only by prescription.


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## Jeffrey Roberts (Apr 15, 1987)

Zelnorm will be in the pharmacies in Canada beginning Monday June 10.It will be sold as 6mg. tablets in a blister pack. The recommended dosage is 2 x 6mg. per day.It will be available only by prescription.


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