Lotronex alosetron selective 5-HT3 receptor antagonist regulatory update

The FDA approved an sNDA to allow a reintroduction of Lotronex with restrictions on its use. The drug's indication has been narrowed to only treating women with severe, diarrhea-predominant Irritable Bowel Syndrome (IBS) who are not responding to conventional IBS therapy. The new indication reduces the potential market to 185,000 Americans, which is about 10% of the original indication, the FDA said. ...