Novartis Zelnorm for chronic constipation
Executive Summary
Novartis will submit Zelnorm sNDA for treatment of chronic constipation in the fourth quarter, company says. Data from 1,348-patient Phase III trial found 41.4% response rate (greater number of spontaneous bowel movements) after four weeks for 2 mg Zelnorm twice a day; 6 mg dose had similar response rate (43.2%). Results were sustained over 12 weeks. Zelnorm was approved by FDA for constipation-predominant irritable bowel syndrome in July 2002 after a protracted review (1"The Pink Sheet" July 29, 2002, p. 3)...