Thursday, May 9, 2013

FDA Approves Amitiza for Opioid-Induced Constipation

We know that, Lubiprostone (marketed under the trade name Amitiza) is a medication used in the management of chronic idiopathic constipation and irritable bowel syndrome. It was approved by the U.S. Food and Drug Administration (FDA) for this purpose on 31 January 2006.

Now, has approved Sucampo’s supplemental new drug application (sNDA) for Amitiza (lubiprostone) (24 mcg twice daily) as the first and only oral medication for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain. The effectiveness of Amitiza in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids (e.g., methadone) has not been established...


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