FDA approves the reintroduction of Zelnorm (tegaserod) for Irritable Bowel Syndrome with Constipation (IBS-C) in women under 65

 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 Despite usage that made Zelnorm the prescription market leader in IBS-C, it was voluntarily withdrawn from the U.S. market in 2007 due to a potential safety signal.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 authorized 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.

Zelnorm is the only selective serotonin-4 (5-HT₄) receptor agonist approved to treat IBS-C. It provides a unique treatment by targeting the 5-HT₄receptor at multiple neurons (sensory, motor, secretory motor) and smooth muscle cells in the gastrointestinal tract to induce contraction and relaxation, and decrease pain signaling. In clinical trials, patients taking Zelnorm saw improvement in some of the most bothersome IBS-C symptoms; in the first four weeks significantly more Zelnorm-treated patients than placebo-treated patients reported an improvement in their abdominal pain/discomfort and bloating. Frequency of bowel movements also increased from a median number of 3.8 per week at baseline to 6.3 per week at month one.

"We are excited about what the reintroduction of Zelnorm means for patients suffering from irritable bowel syndrome with constipation. We have continually heard from patients and clinicians alike that the IBS-C community is eager to have Zelnorm return to the U.S. as an available treatment option," said P. Breckinridge Jones, CEO of US WorldMeds.

Jeffery Roberts, patient advocate and founder of the IBS Patient Group, stated, "The re-approval of Zelnorm is very good news for patients. We believe it will provide renewed access to a treatment option where other new medications have been insufficient for meeting patients' needs."

Register as Visitor to CPhI China 2019!

-----------------------------------------------------------------------
Editor's Note:

To apply for becoming a contributor of En-CPhI.cn,

welcome to send your CV and sample works to us,

Email: Julia.Zhang@ubmsinoexpo.com.