US WorldMeds announced that the Food and Drug Administration (FDA) has approved the reintroduction of Zelnorm (tegaserod) for the treatment of irritable bowel syndrome with constipation (IBS-C) in women aged <65 years. The safety and effectiveness of the treatment has not been established in men with IBS-C.
Zelnorm, a selective serotonin-4 (5-HT4) receptor agonist, was initially approved in 2002 but was voluntarily withdrawn from the market in 2007 due to a potential safety issue regarding an increased risk of heart attack, stroke, and unstable angina.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.
Zelnorm works by targeting the 5-HT4 receptor in the gastrointestinal tract to stimulate peristaltic reflex and intestinal secretion, inhibit visceral sensitivity, enhance basal motor activity, and normalize impaired motility throughout the gastrointestinal tract.
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.
Study patients who received Zelnorm experienced improvements in some of the most bothersome IBS-C symptoms. Specifically, in the first 4 weeks, more patients treated with Zelnorm had improvements with abdominal pain/discomfort and bloating compared with patients who received placebo. There was an increase in frequency of bowel movements from baseline to week 4 with Zelnorm (from 3.8 per week to 6.3 per week). Headache, abdominal pain, nausea, diarrhea, flatulence, dyspepsia, and dizziness were the most commonly reported adverse reactions.
Zelnorm is expected to be available in the coming months in 6mg strength tablets.
For more information call (855) 697-9232 or visit ZelnormUS.com.