Medication Monitor

Generic Name (Trade Name—Company)
April 10, 2019


(Zelnorm—Sloan Pharma/US WorldMeds)
FDA approves reintroduction of tegaserod for IBS-C in women

US WorldMeds announced that its subsidiary, Sloan Pharma, has received FDA approval to reintroduce tegaserod, a twice-daily oral treatment for irritable bowel syndrome with constipation (IBS-C) in women younger than 65.

Tegaserod was originally approved by FDA in 2002 for treatment of IBS-C in women. It was voluntarily withdrawn from the U.S. market in 2007 because of safety concerns. The drug has remained consistently available in the United States through an expanded access program authorized by FDA and is used by patients with IBS-C in several other countries.

Approval to reintroduce the agent came after a complete safety review by FDA and an FDA-assembled Gastrointestinal Drugs Advisory Committee (GIDAC). The review focused on 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 its reintroduction for appropriate patients with IBS-C.

Tegaserod is the only selective serotonin-4 (5-HT4) receptor agonist approved to treat IBS-C. The drug targets the 5-HT4 receptor at multiple neurons (sensory, motor, secretory motor) and smooth muscle cells in the GI tract to induce contraction and relaxation and decrease pain signaling.

In clinical trials, patients taking tegaserod saw improvement in some of the most bothersome IBS-C symptoms. In the first 4 weeks, significantly more patients treated with tegaserod 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.