# New information on Tegaserod (Zelmac)



## Guest (Oct 20, 2000)

This info is from the Novartis webpage...---------------------------------------------About ZelmacZelmac belongs to a new chemical class of compounds which selectively target and act on 5-HT4 receptors present throughout the gastrointestinal (GI) tract. These serotonin receptors appear to play a key role in GI motility and may be involved in pain perception. By acting on the 5-HT4 receptor pathway, Zelmac may improve GI function by relieving abdominal pain and constipation in certain IBS patients.About Irritable Bowel Syndrome (IBS)IBS is a condition associated with the digestive system. In short, it involves hypersensitivity and altered motility of the gastrointestinal tract. Symptoms vary, but the hallmark symptoms of IBS are abdominal pain/discomfort, bloating and symptoms associated with altered bowel function, such as constipation, diarrhea or an alternating pattern of the two. Secondary symptoms associated with IBS include passing of mucous with stools, tiredness, depression, anxiety and irritability.Prevalence of IBSIBS is a surprisingly prevalent condition among the world population ï¿½ surprising because public awareness of the condition is so low despite the widespread nature of the disorder. Up to 20 percent of the world's population is affected by IBS, and of those people who suffer from the condition, approximately 70 percent are estimated to be female. In the US, 25 million people have a form of IBS that includes three major symptoms: abdominal pain, bloating and altered bowel function. Also in the US, IBS accounts for four percent of all primary care physician visits and it is the second most common reason for sick days next to the common cold. Approximately 33 million people in the top-five European countries are affected by the conditionAbout the Zelmac Submission ProcessA new drug application for Zelmac was submitted to the US Food and Drug Administration (FDA) in February 2000, and in April, it was granted priority review. Priority review status is granted by the FDA to products that are considered a potential therapeutic advance over existing therapies or where none exists. On 26 June, the FDA's Gastrointestinal Advisory Committee recommended approval for Zelmac for the treatment of abdominal pain/discomfort and constipation in women with IBS. In August, Novartis received an approvable letter from the FDA for Zelmac. In that letter, the FDA requested additional clinical data. Preliminary data from this recently completed clinical study of 1500 females treated with Zelmac confirm safety and efficacy of the drug for the treatment of abdominal pain/discomfort and constipation in women with IBS. Novartis anticipates providing additional details of this study upon submission of the data to regulatory authorities later this year.A regulatory submission for Zelmac is also currently under review by the European Medicine Evaluation Agency (EMEA) and many other health authorities worldwide. The submissions are based on data from clinical studies involving 2500+ patients in 15 countries. Novartis believes that the data show that Zelmac provides patients with relief from certain key symptoms of IBS, such as abdominal pain and discomfort and constipation. Zelmac was also found to be well-tolerated with side effects comparable to placebo. Diarrhea was the only notable adverse event that was reported more often in Zelmac treatment groups (12% vs. 5% on placebo). Diarrhea is an expected pharmacodynamic effect of the drug and only 1.6% of patients discontinued treatment as a result of it.


----------



## JeanG (Oct 20, 1999)

Thanks, Guy! I notice they are looking at it also for Europe. Our European friends will be happy to hear that.







JeanG


----------

