Alfasigma USA launches IBS-C drug ZELNORM in US

Alfasigma USA has launched ZELNORM (tegaserod) tablets in the US as a prescription drug for irritable bowel syndrome with constipation (IBS-C) in adult women aged under 65 years.

ZELNORM was acquired by Alfasigma USA in July 2019 from Sloan Pharma, a subsidiary of US WorldMeds.

Bryan Downey – president and CEO of Alfasigma USA said: “We are pleased to inform U.S. physicians and pharmacists about the reintroduction of ZELNORM and how Alfasigma USA is supporting the availability, access to, and appropriate use of this important medicine for the many patients who cope daily with an urgent need for new treatment options.

“Our growing U.S. organization and national sales force is excited to lead the return of ZELNORM and committed to making a positive difference in the lives of patients.”

ZELNORM, which was approved originally in 2002 as the first prescription drug for IBS-C, was withdrawn voluntarily from the market in 2007 because of concerns about possible cardiovascular risk.

In March 2019, ZELNORM was re-approved in the US in use in adult women aged less than 65 years with IBS-C, after a safety review by the regulator and a Gastrointestinal Drugs Advisory Committee (GIDAC) assembled by it. The evaluation of the IBS-C drug included a review of clinical data derived from 29 placebo-controlled trials and post-marketing treatment outcome data.

John Kincaid – Alfasigma USA head of medical affairs said: “ZELNORM addresses an area of clear unmet medical need and there is a robust body of data supporting its safe and effective use when used as indicated for adult women in the U.S. suffering from IBS-C.”

According to Alfasigma USA, ZELNORM is the only serotonin-4 (5-HT4) receptor agonist to be approved for IBS-C treatment. The IBS-C drug targets the 5-HT4 receptor at various neurons and smooth muscle cells in the gastrointestinal tract to help in contraction and relaxation, and reduce pain signaling.

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