Sucampo lubiprostone NDA submitted
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Sucampo expects a standard review for its chronic idiopathic constipation agent lubiprostone, putting the user fee deadline at Jan. 31, 2006. The firm believes the oral chloride channel activator "may offer a more targeted approach to managing the symptoms of constipation." Novartis' 5-HT4 antagonist Zelnorm (tegaserod) gained a chronic constipation indication in August 2004. Sucampo is also studying lubiprostone for post-operative ileus and constipation-predominant irritable bowel syndrome (1Pharmaceutical Approvals Monthly November 2003, p. 12)...