FDA approves Zelnorm for chronic constipation
Swiss company Novartis Pharma has received US FDA approval of a supplemental indication for its promotility agent Zelnorm (tegaserod maleate) for the treatment of chronic idiopathic constipation in male and female patients less than 65 years of age.
Swiss company Novartis Pharma has received US FDA approval of a supplemental indication for its promotility agent Zelnorm (tegaserod maleate) for the treatment of chronic idiopathic constipation in male and female patients less than 65 years of age.
The new indication is supported by safety and efficacy data from the two largest and longest randomised, double-blind, placebo-controlled, multi-national Phase III clinical trials ever conducted in chronic constipation, which lasted three months and included more than 2,600 patients. In addition, one of the studies included a 13-month extension safety study of 840 patients. Zelnorm was found to significantly increase the frequency of complete spontaneous bowel movements as well as to provide relief of the multiple symptoms of chronic constipation that patients complain about most.
Zelnorm has been available since July 2002 to provide women with the relief of abdominal discomfort or pain, bloating and constipation associated with irritable bowel syndrome (IBS). As a promotility agent, it acts as an agonist at 5HT4 receptors in the GI tract and mimics the natural effects of serotonin by activating 5HT4 receptors, which normalises impaired motility in the GI tract, inhibits visceral sensitivity and stimulates intestinal secretion.
Zelnorm, known in some countries as Zelmac, is approved in more than 55 countries for IBS with constipation, and is also approved for use in chronic constipation in 10 countries, including Mexico and Latin America. It is being studied as a potential treatment for other important GI motility disorders, including gastroesophageal reflux disease (GERD) and dyspepsia.