FDA Approves New Constipation Drug

Susan Farley
Published Online: Saturday, April 1, 2006

A new prescription drug, lubiprostone (Amitiza), has been approved for the treatment of chronic idiopathic constipation in adults. This capsule form of lubiprostone increases the secretion of intestinal fluid, which then eases the passage of stool and alleviates constipation symptoms. Two clinical trials were conducted to test the drug's efficacy. Patients participating in the trial had had, on average, fewer than 3 spontaneous bowel movements per week and had experienced symptoms of constipation for at least 6 months. In the trials, lubiprostone yielded a higher frequency of bowel movements in the first week than the placebo. Similar results continued for weeks 2, 3, and 4. Studies over 6 to 12 months showed that the drug decreased constipation severity, abdominal bloating, and discomfort. Common side effects of lubiprostone were headache, nausea, diarrhea, abdominal pain, and distention, which may or may not be associated with the drug. It is being marketed by Sucampo Pharmaceuticals and Takeda Pharmaceuticals America.

Ms. Farley is a freelance medical writer based in Wakefield, RI.

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