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US WorldMeds reintroduces Zelnorm (tegaserod) for treating IBS-C in women under 65.

M2 EQUITYBITES-April 2, 2019-US WorldMeds reintroduces Zelnorm (tegaserod) for treating IBS-C in women under 65

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Pharmaceutical company US WorldMeds revealed on Monday the receipt of approval from the US Food and Drug Administration (FDA) for the relaunch of its twice-daily oral Zelnorm (tegaserod) treatment for Irritable Bowel Syndrome with Constipation (IBS-C) in women under 65.

The US FDA approval was awarded to Sloan Pharma, Sarl, a subsidiary of US WorldMeds Holdings LLC.

In 2002, Zelnorm was originally approved by the US FDA for treating IBS-C in women, but was voluntarily withdrawn from the US market in 2007 due to a potential safety signal. However, it has remained consistently available through an expanded access programme in the US as well as in several other countries, added the company.

Following a complete safety review by the US FDA and an US FDA-assembled Gastrointestinal Drugs Advisory Committee (GIDAC), the re-approval and its relaunch focused on the evaluation of positive clinical data from 29 placebo-controlled trials and newly-available sources of treatment outcome data for the treatment of appropriate IBS-C patients. Zelnorm showed symptomatic relief within the first month of treatment across three controlled clinical studies, disclosed the company.

According to the company, Zelnorm is the only selective serotonin-4 (5-HT4) receptor agonist approved to treat IBS-C. It targets the 5-HT4 receptor at multiple neurons (sensory, motor, secretory motor) and smooth muscle cells in the gastrointestinal tract to induce contraction and relaxation and decrease pain signalling.

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Publication:M2 EquityBites (EQB)
Date:Apr 2, 2019
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