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Abbott Presents Results of Clinical Studies Evaluating Its Investigational Treatment for Advanced Parkinson's Disease
Date:6/18/2012

DUBLIN, June 18, 2012 /PRNewswire/ -- Today Abbott (NYSE: ABT) announced results from five abstracts evaluating levodopa-carbidopa intestinal gel (LCIG), its investigational compound for advanced Parkinson's disease. The abstracts include the results from the second interim analysis of a long-term safety and tolerability trial, as well as secondary endpoint analyses from the Phase 3 pivotal trial. All of the abstracts were presented at The 16th International Congress of Parkinson's Disease and Movement Disorders, June 17-21 in Dublin, Ireland.

LCIG is currently approved in 40 countries. In the U.S., LCIG is an investigational therapy that is currently being evaluated in patients with advanced Parkinson's disease in additional Phase 3 clinical trials. In these trials, levodopa-carbidopa is administered in gel form, directly into the small intestine via a procedurally-implanted tube connected to a portable pump that delivers continuous supply of LCIG during awake hours.

Long-Term Safety and Tolerability
In a 54 week open-label safety and tolerability study of 354 patients with advanced Parkinson's disease, the primary endpoint of safety showed adverse events (AEs) were mostly mild to moderate, were generally associated with the Percutaneous Endoscopic Gastrostomy (PEG) tube placement procedure and its complications, were transient, and resolved over time.

In the secondary endpoint analysis from the open-label study, patients experienced an average daily "off" time of 6.7 hours, and 7.7 hours of "on" time without troublesome dyskinesia at baseline. "Off" time refers to periods of poor mobility, slowness and stiffness experienced by patients with Parkinson's disease, while "on" time refers to periods of good motor symptom control. At week 54, mean daily "off" time had decreased an average of 4.5 h
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SOURCE Abbott
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