New data confirms long-term safety of Novartis' Zelmac in IBS

Data from a new long-term safety and tolerability study found that 62%of irritable bowel syndrome patients reported considerable relief of symptoms at 12 months when treated with Novartis' Zelmac (tegaserod). Both the European Medicines Evaluation Agency and the US Food and Drug Administration rejected approval of the drug for an IBS indication earlier this year (Marketletters June 11 and 25).

The new data, from a multicenter, dose-titration study evaluating 579 patients to reinforce past studies that established the safety of Zelmac, was presented at the United European Gastroenterology Week meeting held in Amsterdam, the Netherlands. The drug was found to be safe and well-tolerated, with mild side effects, the most common being transient diarrhea (10%) and headache (8%). Patients treated with Zelmac showed no hematological or biochemical abnormalities, and blood pressure and pulse rate remained normal, as did the results of urinalysis, according to Novartis. Previous clinical trials involving more than 4,500 patients found that two-thirds treated with Zelmac experienced overall symptom relief, including in abdominal pain and constipation.

Zelmac is approved for the treatment of abdominal pain, bloating and constipation in IBS patients in Mexico, Venezuela, Colombia and the Czech Republic. Also, the Swiss regulatory authorities are due to rule on the drug in the near future. Novartis says it remains committed to working with the FDA and EMEA, as well as other regulatory bodies, "to help bring the benefits of this new therapy to patients in need."