FDA OKs Drug to Treat Constipation

Feb. 1, 2006 — The FDA has affirmed Amitiza, the first medicate of its chemical sort, to treat inveterate stoppage in grown-ups.

Amitiza will be accessible as capsules for utilize by adults to treat chronic clogging that doesn’t have a known cause (such as other diseases or use of drugs).

Chronic constipation is generally defined as occasional and troublesome passage of stool. One of America’s most common disarranges, unremitting clogging is more often seen in women and in adults matured 65 and older. Symptoms are stomach torment and distress, bloating, straining, and difficult stools.

Amitiza works by expanding the secretion of intestinal fluid discharge, which makes a difference ease stool entry and stoppage symptoms. The medicate should be taken twice day by day with food. Specialists and patients should periodically evaluate the require for proceeded treatment, states an FDA news discharge.

Amitiza’s Endorsement

The FDA based its choice to favor Amitiza on the comes about from two clinical trials. When the trial began, participants averaged less than three spontaneous bowel developments per week; they had had constipation indications for at least the final six months.

The studies appeared that patients treated with Amitiza had more frequent bowel movements in the first week than those taking a fake sedate (fake treatment). In both considers, similar results were seen for the next three weeks of treatment.

In expansion, three long-term studies showed that Amitiza decreased clogging severity, stomach bloating, and discomfort over six to 12 months of utilize.

The most common unfavorable occasions detailed in the trials included headache, queasiness, the runs, abdominal torment, and distension. Whether these events are related to the sedate is not yet known.

Amitiza is marketed by Sucampo Pharmaceuticals, Inc., of Bethesda, Md., and by Takeda Pharmaceuticals America of Lincolnshire, Sick.

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