Novartis reported that the FDA has approved a supplemental indication for its
pro-motility agent Zelnorm 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
mrandomized, double-blind, placebo-controlled, multi-national Phase III clinical trials ever
conducted in chronic constipation, according to Novartis. The two three-month trials included
more than 2,600 male and female 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.