FDA approves lubiprostone (Amitiza) for IBS with constipation

May 2, 2008

Constipation drug lubiprostone is granted FDA approval for new indication.

Sucampo and Takeda Pharmaceuticals have been granted FDA approval to market lubiprostone (Amitiza) for the treatment of irritable bowel syndrome with constipation (IBS-C) in adult women. According to the manufacturers, lubiprostone is the first prescription drug treatment of IBS-C in the United States, a condition that affects twice as many women as men. Safety and efficacy were evaluated in two studies involving 1,154 patients with the condition. Results showed more patients receiving lubiprostone reported their IBS symptoms were moderately or significantly relieved over a 12-week treatment period than patients who received placebo. The new indication calls for the drug to be taken in an 8-mcg dose twice daily with food and water. Lubiprostone was previously approved for treatment of chronic idiopathic constipation in a higher 24-mcg twice-daily dosage.

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