FDA Approves Zelnorm for Constipation

OCTOBER 01, 2004

On August 23, 2004, the FDA approved Zelnorm (Novartis Pharmaceuticals, East Hanover, NJ) for the treatment of chronic idiopathic constipation in male and female patients younger than 65 years of age. This makes Zelnorm the first FDA-approved prescription medication for use in patients with chronic constipation. Other available agents are indicated only for use in patients with occasional constipation. The FDA's decision was based on efficacy and safety data from 2 of the largest and longest randomized, double-blind, placebo-controlled, multinational, phase 3 trials conducted in chronic constipation. The two 3- month trials included more than 2600 male and female patients. Compared with placebo, Zelnorm was found to significantly increase the frequency of complete spontaneous bowel movements and to provide relief of the symptoms of chronic constipation for which patients seek help most often, including straining, hard stool, sense of incomplete evacuation, infrequent defecation, bloating, and abdominal discomfort.


Become A RESPIMAT T.O.P. Performer 

Get to know RESPIMAT, the slow-moving mist inhaler from Boehringer Ingelheim Pharmaceuticals, Inc.

Watch the RESPIMAT video and test your knowledge with a short multiple-choice quiz. When you get all the answers right, you’ll receive a certificate naming you a RESPIMAT T.O.P. Performer. Why not check it out today?

Pharmacy Times Strategic Alliance

Pharmacist Education
Clinical features with downloadable PDFs

Next-Generation Pharmacist® Awards

3rd Annual Convenient Healthcare and Pharmacy Collaborative Conference

Personalize the information you receive by selecting targeted content and special offers.