A product of Sucampo Pharmaceuticals, Inc. (706843) - AMITIZA® (lubiprostone) – has been approved in January 2006 by the USFDA for the treatment of Chronic Idiopathic Constipation (CIC) in adults.
Now, Sucampo has commenced two clinical studies of AMITIZA® (lubiprostone) in subjects with either renal or hepatic impairment in order to evaluate the safety and pharmacokinetic profile of a single oral dose (24 mcg) of AMITIZA - which will fullfill the company’s commitment to the USFDA to conduct renal and hepatic impairment post-marketing studies of AMITIZA®.
According to Philip B. Miner, President and Medical Director of the Oklahoma Foundation of Digestive Research and Clinical Professor of Medicine at the University of Oklahoma:
Find more details from the press release."Studies evaluating the safety and efficacy of newly released drugs in special patient populations provide the practicing physician with valuable information relevant to effective patient care.
Patients with compromised kidney and liver function are particularly difficult to manage because of the importance of the liver and kidney in the metabolism of drugs.
These new clinical trials will be very useful for making clinical decisions regarding the safe use of AMITIZA for these particular patient groups."
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