RESEARCH TRIANGLE PARK, NC — June 7, 2002 —
Today the U.S. Food and Drug Administration (FDA) approved the Supplemental New Drug Application (sNDA) for Lotronex® (alosetron hydrochloride) Tablets which provides for the re-introduction of the medicine to the marketplace under restricted conditions of use.
Lotronex Tablets will be indicated specifically for use in women with severe diarrhea-predominant irritable bowel syndrome who have failed to respond to conventional therapy, whose IBS symptoms are chronic and who have had other gastrointestinal medical conditions that could explain their symptoms ruled out.
Symptoms that make diarrhea-predominant IBS severe are frequent and serious abdominal pain, fecal incontinence or the uncontrolled urge to have a bowel movement, or curtailment of daily activities because of IBS. Serious gastrointestinal events, specifically ischemic colitis and complications of constipation, have been reported in association with the use of Lotronex. These events have resulted in hospitalization, blood transfusion and/or surgery and some fatalities. In clinical trials, about three women in 1,000 developed ischemic colitis over six months.
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