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281 Views 1 Reply 2 Participants Last post by  JenS
Talked with a Norvartis rep today who says Zelmac (it will apparently have a different name) is due to be approved by the FDA June 18 for IBS-CP, with likely availablity by prescription in late July or early August. He seemed optimistic about the chances for reintroduction of Lotronex as well, but no inside information about a timetable.
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This is an older article, but wanted to post for the "newbies" on the board.FDA Committee Recommends Zelmac (Tegaserod) For Women With Irritable Bowel SyndromeGAITHERSBURG, MD -- June 27, 2000 -- Novartis Pharmaceuticals Corporation (announced that the Food and Drug Administration's (FDA) Gastrointestinal Drugs Advisory Committee recommended approval for Zelmac � (tegaserod) for the treatment of abdominal pain or discomfort and constipation in women with irritable bowel syndrome (IBS). Currently, there is no effective treatment for the millions of patients who suffer from these symptoms."Today's recommendation supporting the approval of Zelmac brings us closer to providing a new, safe and effective treatment for the millions of women who suffer from abdominal pain or discomfort and constipation with IBS," stated Joerg Reinhardt, Head of Development, Novartis. "We look forward to working with the FDA to finalize the approval of Zelmac."A new drug application (NDA) for Zelmac was submitted to the FDA on February 11, 2000 and was granted priority review. Similarly, a regulatory submission was filed with the European Medicine Evaluation Agency (EMEA) on February 16. The FDA Committee's recommendation will be forwarded to the FDA, which will make the final decision on marketing approval. Although the Committee's recommendation is not binding, when making a final decision the FDA will carefully consider it.IBS is one of the most common gastrointestinal (GI) disorders of function, affecting up to 20 percent of the Western population. It is a chronic condition characterized by abdominal pain, bloating and symptoms associated with irregular bowel function, such as constipation, diarrhea or an alternating pattern between the two.Zelmac belongs to a new chemical class of compounds which selectively target and act on 5-HT4 receptors present throughout the GI tract. These serotonin receptors may potentially play a key role in pain perception and GI motility. By acting on the 5-HT4 receptor pathway, Zelmac may reduce abdominal pain and normalize altered GI function in IBS patients who suffer from abdominal pain and constipation as their primary symptoms.In a development program with over 2000 patients, Zelmac was found to be well-tolerated with side effects comparable to placebo. Diarrhea was the predominant adverse event reported more often in Zelmac treatment groups (12 percent on Zelmac vs. 5 percent on placebo). In most cases, the diarrhea occurred early, was transient, and resolved without discontinuation of therapy. Only 2.1 percent of patients discontinued Zelmac therapy due to diarrhea compared to 0.6 percent on placebo.Novartis is also assessing Zelmac as a potential treatment for other GI disorders of function such as gastroesophageal reflux disease (GERD) and functional dyspepsia.Related Links: Zelmac (tegaserod) and Novartis Pharmaceuticals Corporation.
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