New prescription constipation drug

New prescription constipation drug for adults approved by FDA
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Mar 6 (HealthCentersOnline) - The US Food and Drug Administration (FDA) recently approved a new prescription medication for the treatment of chronic constipation of unknown origin in adults. The drug, which is called Amitiza (lubiprostone), has a unique chemical type and will be available in capsule form to treat adults with chronic idiopathic constipation.

Chronic idiopathic constipation is difficult or infrequent passage of food product waste (stool) through the anus that cannot be attributed to any known factors such as disease or medication use. It develops gradually and lasts for long periods of time.

Chronic idiopathic constipation is among the most common conditions affecting Americans. Women and people over age 65 are at increased risk for the disorder.

Symptoms of chronic idiopathic constipation include bloating, abdominal discomfort and pain, straining to pass stools and hard stools.

Amitiza increases the secretion of intestinal fluid in the body. This, in turn, helps to ease stool passage and alleviate other symptoms of chronic idiopathic constipation.

The FDA decided to approve the use of Amitiza for chronic idiopathic constipation in adults based on the results of two clinical trials. On average, subjects experienced constipation symptoms for a minimum of six months and fewer than three spontaneous bowel movements a week before participating in the studies.

Subjects who were given Amitiza had more bowel movements in the first week than those who were given placebos. In both studies, the same results were duplicated in three subsequent weeks of therapy. Additionally, three long-term studies demonstrated that the drug reduced abdominal bloating and discomfort as well as the severity of constipation over a six to 12 month period.
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According to study participants, nausea, headache, diarrhea, distension and abdominal pain were the most common adverse events experienced with use of Amitiza. It is unknown at this time whether these events were related to use of the drug.

The medication is marketed by both Sucampo Pharmaceuticals, Inc., Bethesda, MD. and Takeda Pharmaceuticals America, Lincolnshire, IL. It should be taken twice daily with food. The FDA recommends that physicians monitor patients who take Amitiza and periodically assess whether continued treatment is necessary.

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Publish Date: March 06, 2006