Supplement-Drug eases discomfort of irritable bowel
Supplement-Drug eases discomfort of irritable bowel
The Food and Drug Administration (FDA) in Rock ville, MD, recently approved Lotronex (alosetron hydrochloride), manufactured by Glaxo Wellcome in Research Triangle Park, NC, for the treatment of women who suffer from irritable bowel syndrome-associated abdominal pain and diarrhea.
Lotronex is a selective 5-HT3 antagonist and the first of a new generation of agents designed specifically for the treatment of irritable bowel syndrome to receive FDA approval. The approval was based on data from two large, phase III clinical trials showing that Lotronex was superior to placebo in providing relief of irritable bowel pain and discomfort, decreasing the urgency to go to the bathroom and reducing stool frequency in women with diarrhea-dominant irritable bowel syndrome.
Bowel function improved in a week
Relief of pain and discomfort occurred by the end of the first week of treatment in one study and by the end of the fourth week in the second study. Improvements in bowel function in both studies occurred by the end of the first week of treatment and continued through the 12-week treatment periods. One week following discontinuation of the drug, symptoms returned.
Lotronex should not be used in patients who are currently constipated or whose predominant bowel symptom is constipation. Safety and efficacy in men have not been determined.
For full prescribing information via fax, dial (800) 753-0352, ext. 733.
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