The FDA has approved the reintroduction of Zelnorm, a twice-daily oral treatment for irritable bowel syndrome with constipation in women aged under 65 years, according to a company press release.
The FDA originally approved tegaserod (Zelnorm, Sloan Pharmaceuticals) in 2002 for the treatment of IBS-C in women. However, Novartis, the drug’s previous manufacturer, voluntarily pulled tegaserod from the U.S. market in 2007 due to possible cardiac-related side effects.
Tegaserod has been available in the U.S., but only through an FDA-authorized expanded access program.
“We are excited about what the reintroduction of Zelnorm means for patients suffering from irritable bowel syndrome with constipation,” P. Breckinridge Jones, CEO of U.S. WorldMeds, said in the press release. “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.”
The approval to reintroduce tegaserod, according to the release, is a result of a complete safety review from the FDA and the FDA Gastrointestinal Drugs Advisory Committee (GIDAC).
The review evaluated clinical data from 29 placebo-controlled trials, as well as newly-available sources of treatment outcome data.
A selective serotonin-4 (5-HT4) receptor agonist, tegaserod targets the 5-HT4 receptor across multiple neurons and smooth muscle cells in the gastrointestinal tract to induce contraction and relaxation, and decrease pain signaling.
Results of three double-blind, placebo-controlled trials that comprised 2,470 adult women demonstrated symptom improvement from baseline after 1 month of receiving tegaserod compared with placebo, according to the release.
Sloan Pharmaceuticals, a subsidiary of U.S. WorldMeds, acknowledged in the release that there remains an increased risk for cardiac events, including myocardial infarction and stroke, when using tegaserod.