Zelnorm (tegaserod) is found both effective and well tolerated in the treatment of Irritable Bowel Syndrome with Constipation (IBS-C), according to the data presented at the 2004 United European Gastroenterology Week (UEGW) congress.

Zelnorm 6 mg, twice daily, provided patients with statistically significant improvement of their overall IBS symptoms as well as for the specific endpoint of improvement in abdominal discomfort or pain relief. Zensaa (Zelnorm in Europe, North and South America and Africa) is the largest trial of a dysmotility disorder like IBS-C ever conducted, having included more than 2,600 patients, according to a release from Novartis.

"These positive results illustrate what we've known about Zelnorm all along; it has the distinction of treating the multiple dysmotility symptoms associated with IBS to the satisfaction of both physicians and patients," Joerg Reinhardt, head of Development, Novartis Pharma AG said adding, "Because Zelnorm holds the promise of treating the tens of thousands of underserved people who now suffer from IBS-C, we remain committed to bringing Zelnorm to market in the European Union."

Designed in line with the recommendations of the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA), ZENSAA was set up to assess initial and repeated Zelnorm treatment, as well as the effect on quality of life measures for women suffering from the multiple dysmotility symptoms of IBS-C, the release added.

Lead investigator, Professor Jan Tack, associate professor and associate head of Clinic, Department of Gastroenterology, University of Leuven, Belgium said, "The exact trial design of Zensaa, its broad scope and the volume of patients leave no doubt about the effectiveness of tegaserod in treating IBS with Constipation."

The trial was also designed to mirror clinical practice as closely as possible within the clinical trial setting. The positive results from the Zensaa trial will be used to support the upcoming EMEA filing of Zelnorm for the treatment of IBS-C in the European Union.

Zensaa was designed to assess the efficacy, safety and tolerability of Zelnorm during both short-term (4 week) treatment and re-treatment at recurrence of symptoms; daily and weekly symptom evaluation; quality of life including work productivity; and overall patient-reported satisfaction with treatment. For the work productivity measures, at the end of the trial, treatment with Zelnorm reduced absenteeism (work missed due to symptoms) by 2.6% vs. placebo (p= 0.0042) and reduced "presenteeism" (loss productivity while at work) by 5.4% (p=0.0001).

Irritable Bowel Syndrome with constipation (IBS-C) is a chronic, recurrent dysmotility disorder characterized by the multiple symptoms of abdominal pain and discomfort, bloating, and constipation.

Zelnorm (tegaserod), a pro-motility agent, is the first in a newer class of medications known as serotonin-4 receptor agonists (5HT4 agonists) specifically developed to treat the multiple symptoms associated with dysmotility disorders like IBS-C. By activating 5HT4 receptors in the gastrointestinal tract, Zelnorm normalizes delayed motility and reduces sensitivity of the intestinal tract.

Zelnorm, discovered and developed by Novartis, is approved for the treatment of IBS in more than 50 countries including Australia, Switzerland, Canada, the United States, Mexico, China and Brazil. Zelnorm is also approved for the treatment of Chronic Constipation in more than 10 countries including the United States and Mexico.