Printer Friendly

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


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In 2002, Zelnorm was originally approved by the US FDA for treating IBS-C in women, but was voluntarily withdrawn from the US market in 2007 due to a potential safety signal.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.

((Comments on this story may be sent to

COPYRIGHT 2019 Normans Media Ltd.
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2019 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:M2 EquityBites (EQB)
Date:Apr 2, 2019
Previous Article:Mace Security appoints Julie Koenig as new VP of Sales.
Next Article:Medley Management reports Q4 2018 results and dividend of USD0.03 per share.

Terms of use | Privacy policy | Copyright © 2019 Farlex, Inc. | Feedback | For webmasters