Novartis Pharma AG announced that the US FDA approved a supplemental indication for its pro-motility 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 randomized, double-blind, placebo-controlled, multi-national Phase III clinical trials ever conducted in chronic constipation. The two three-month trials included more than 2,600 male and female 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, including straining, hard stool, incomplete evacuation, infrequent defecation, bloating and abdominal discomfort, release from Novartis said.
"Chronic constipation has a tremendous impact on patients' lives, with nearly a million visits to emergency rooms every year, almost six million visits to doctors' offices, and thousands of hospitalizations," said Joerg Reinhardt, Head Development, Novartis Pharma AG. "We are very pleased the FDA has found Zelnorm safe and effective and has approved it for treatment of patients with chronic constipation. Novartis believes it will help bring relief to millions of patients," he continued.
Zelnorm has been available since July 2002 as the first and only prescription medication proven to provide women with the relief of abdominal discomfort or pain, bloating and constipation associated with irritable bowel syndrome (IBS). IBS with constipation and chronic idiopathic (meaning not due to other diseases or drugs) constipation are both lower gastrointestinal dysmotility disorders.
A recent survey with 557 patients found that 47 per cent of patients with chronic constipation were not completely satisfied with currently available therapies due to the efficacy of these agents (82 per cent) and the safety and side effects (16 per cent). More than half (52 per cent) of respondents felt that chronic constipation adversely impacted their quality of life, the release added.
As a pro-motility agent, Zelnorm acts as an agonist at 5HT4 (serotonin type 4) receptors in the GI tract and mimics the natural effects of serotonin by activating 5HT4 receptors, which normalizes impaired motility in the GI tract, inhibits visceral sensitivity and stimulates intestinal secretion. Zelnorm treats dysmotility symptoms caused by chronic constipation and IBS with constipation.
Zelnorm was developed by Novartis and is also known in some countries as Zelmac. It is approved in more than 55 countries for IBS with constipation.