Posted by Michael Wonder on 04 Apr 2019
FDA approves the reintroduction of Zelnorm (tegaserod) for irritable bowel syndrome with constipation in women under 65
1 April 2019 - In clinical trials, patients taking Zelnorm saw improvement in some of the most bothersome IBS-C symptoms, including abdominal pain/discomfort, bloating, and stool frequency.
US WorldMeds has announced that Sloan Pharma, S.a.r.l., a subsidiary of US WorldMeds Holdings, LLC, has received approval from the U.S. Food and Drug Administration (FDA) for the reintroduction of Zelnorm (tegaserod), a twice-daily oral treatment for Irritable Bowel Syndrome with Constipation (IBS-C) in women under 65.
Zelnorm was originally approved by the FDA in 2002 for the treatment of IBS-C in women. Despite usage that made Zelnorm the prescription market leader in IBS-C, it was voluntarily withdrawn from the U.S. market in 2007 due to a potential safety signal. Zelnorm has remained consistently available in the U.S. through an expanded access program authorised by the FDA and is used by IBS-C patients in several other countries.
Approval to reintroduce Zelnorm comes after a complete safety review by the FDA and an FDA-assembled Gastrointestinal Drugs Advisory Committee (GIDAC). The review focused on the evaluation of clinical data from 29 placebo-controlled trials and newly-available sources of treatment outcome data. A positive GIDAC vote and FDA review both supported the reintroduction of Zelnorm for appropriate IBS-C patients.
