Zelnorm (tegaserod; Alfasigma) is available again for the treatment of irritable bowel syndrome with constipation (IBS-C) in adult women <65 years of age.
Zelnorm, a selective serotonin-4 (5-HT4) receptor agonist, was initially approved in 2002 but was voluntarily withdrawn from the market in 2007 due to a potential safety issue regarding an increased risk of heart attack, stroke, and unstable angina. Since then, the product had only been available through an FDA-authorized expanded access program.
The approval for reintroduction to the market was based on a safety review conducted by the FDA and an FDA-assembled Gastrointestinal Drugs Advisory Committee (GIDAC). Data from 29 placebo-controlled trials, in addition to new treatment outcome data were reviewed, which was followed by a positive GIDAC vote.
“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 US suffering from IBS-C,” said John Kincaid MD, head of medical affairs at Alfasigma USA.
The safety and effectiveness of Zelnorm has not been established in men with IBS-C. In 2 randomized, placebo-controlled, double-blind trials enrolling 288 males, efficacy response rates were similar between Zelnorm and placebo in the male subgroup.
Zelnorm is supplied as 6mg tablets in a box containing 60 tablets.
For more information visit zelnormhcp.com.