RESEARCH TRIANGLE PARK, N.C. … The U.S. Food and Drug Administration has approved the Supplemental New Drug Application for Lotronex tablets, which provides for the reintroduction of the medicine to the marketplace under restricted conditions of use.

GlaxoSmithKline pulled Lotronex, the trade name for alosetron hydrochloride, from the market in November 2000 when the company and the FDA couldn’t agree on a plan that would guide appropriate use of the drug without presenting undue problems for patients.

Serious gastrointestinal events, specifically ischemic colitis and complications of constipation, have been reported in association with the use of Lotronex. These problems have resulted in hospitalization, blood transfusion, surgery and some fatalities.

Under the Supplemental NDA, 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.

GSK and the FDA have worked on the Supplemental NDA for more than a year, after thousands of patients who had successfully used Lotronex implored the company and the agency to work out a plan that would allow them access to Lotronex.

“We are pleased with the significant efforts that both we and the FDA put into finding a resolution,” GSK Senior Vice President and Chief Medical Officer Peter Traber said in a statement. “We and the FDA always had the same goal during our discussions … to provide an effective medicine to appropriate patients. We are pleased to have been able to work out a risk management plan that will allow the most severely affected IBS patients access to Lotronex.”

GSK is working to resume manufacture of Lotronex and to finalize details of how the risk management plan will be implemented. The company also will develop the supporting physician and pharmacist-directed educational materials, and it has committed to post-marketing (Phase IV) studies that would evaluate the safety and efficacy of lower doses of Lotronex and of taking Lotronex on an “as needed” basis.

GlaxoSmithKline website: www.gsk.com