Novartis receives supplemental indication for pro-motility agent Zelnorm
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.