The U.S. Food and Drug Administration has confirmed that lubiprostone, brand name Amitiza, has been approved as the only prescription drug therapy FDA approved treatment for Irritable Bowel Syndrome with Constipation (IBS-C) in women over 18.
"For some people IBS can be quite disabling, making it difficult for them to fully participate in everyday activities," said Julie Beitz, M.D., director of the Office of 
Drug Evaluation III, Center for Drug Evaluation and Research, FDA. "This drug represents an important step in helping to provide medical relief from their symptoms."
IBS symptoms include cramping, abdominal pain, bloating, constipation and diarrhea and the illness seems to affect 2x the number of woman as men.
The safety and efficacy studies of Amitiza involved 1,154 patients previously diagnosed with IBS-C over a period of 9 to 13 months. 92% of the patients were women and 8% men. The medication was not conclusively shown to be effective on male patients and thus the approval was granted only for women.
Amitiza is manufactured by Sucampo Pharmaceuticals and Takeda Pharmaceuticals.
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