WEDNESDAY, April 30 (HealthDay News) -- The U.S. Food and Drug Administration announced this week that it has approved Amitiza (lubiprostone) for the treatment of irritable bowel syndrome with constipation (IBS-C) in women aged 18 and older.
Amitiza, which is made by Sucampo Pharmaceuticals in Bethesda, Md., and Takeda Pharmaceuticals America, Inc. in Deerfield, Ill., is approved for use in women, but not in children or men. Irritable bowel syndrome, a disorder characterized by symptoms of cramping, abdominal pain, bloating, constipation and diarrhea, affects at least twice as many women as men.
Two major studies involving 1,154 patients with IBS-C demonstrated the safety and efficacy of Amitiza in women. Patients receiving Amitiza experienced moderate or significant relief of symptoms over the 12-week treatment period compared to patients receiving placebo. However, the efficacy of Amitiza in men could not be conclusively established. A longer-term study confirmed the safety of Amitiza over a nine- to 13-month treatment period. Common side effects included nausea, diarrhea and abdominal pain.
"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 at the FDA's Center for Drug Evaluation and Research. "This drug represents an important step in helping to provide medical relief from their symptoms."
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