FDA OKs Amitiza for treatment of IBS-C

April 30, 2008

The U.S. Food and Drug Administration announced approval of Amitiza (lubiprostone) to treat constipation associated with irritable bowel syndrome.

The FDA said it approved Amitiza for use by adult women aged 18 and over, making the drug the only FDA-approved treatment for IBS-C available in the United States.

Irritable bowel syndrome is a characterized by cramping, abdominal pain, bloating, constipation and diarrhea. It causes a great deal of discomfort and distress to its sufferers, but affects at least twice as many women as men.

"For some people IBS can be quite disabling, making it difficult for them to fully participate in everyday activities," said Dr. Julie Beitz, director of the FDA's Office of Drug Evaluation III. "This drug represents an important step in helping to provide medical relief from their symptoms."

The efficacy of Amitiza in men wasn't conclusively demonstrated for IBS-C and the drug isn't approved for use by children or men. The FDA said it also approved Amitiza for the treatment of chronic idiopathic constipation.

Amitiza is manufactured by Sucampo Pharmaceuticals of Bethesda, Md., and Takeda Pharmaceuticals America Inc. of Deerfield, Ill.

Copyright 2008 by United Press International

Related Stories

Recommended for you

How the finch changes its tune

August 3, 2015

Like top musicians, songbirds train from a young age to weed out errors and trim variability from their songs, ultimately becoming consistent and reliable performers. But as with human musicians, even the best are not machines. ...

Cow embryos reveal new type of chromosome chimera

May 27, 2016

I've often wondered what happens between the time an egg is fertilized and the time the ball of cells that it becomes nestles into the uterine lining. It's a period that we know very little about, a black box of developmental ...

Shaving time to test antidotes for nerve agents

February 29, 2016

Imagine you wanted to know how much energy it took to bike up a mountain, but couldn't finish the ride to the peak yourself. So, to get the total energy required, you and a team of friends strap energy meters to your bikes ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.