Sucampo Pharmaceuticals Inc. (SCMP: Quote) and Takeda Pharmaceuticals U.S.A., Inc. or TPUSA announced that the U.S. Food and Drug Administration or FDA has granted priority review of their supplemental new drug application or sNDA filing.
The sNDA was filed in late July seeking approval for an additional indication for AMITIZA (lubiprostone) for the treatment of opioid-induced constipation or OIC in patients with chronic, non-cancer pain.
The FDA's priority review, which allows for an abbreviated review period of six months, is granted to drugs that offer either significant advances in treatment or provide a treatment where there is no existing adequate therapy. As a result of this priority review, Sucampo and Takeda expect the FDA's decision by late January 2013.
Amitiza (lubiprostone) is a chloride channel activator indicated for the treatment of chronic idiopathic constipation (CIC) (24 mcg twice daily) in adults and for irritable bowel syndrome with constipation (8 mcg twice daily) in women 18 years of age and older by the FDA in the United States.
Amitiza (lubiprostone) is approved in Japan for the treatment of chronic constipation (excluding constipation caused by organic diseases); in Switzerland for CIC; and in the United Kingdom for CIC.
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by RTT Staff Writer
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