Abbott Laboratories (ABT) announced the results from a Phase 3 trial evaluating the company's investigational compound for advanced Parkinson's disease, levodopa-carbidopa intestinal gel or LCIG.
The company said that the study showed that patients treated with LCIG for 12 weeks reported clinically meaningful and statistically significant improvements in "off" time compared to levodopa-carbidopa immediate release or IR tablets, without increasing troublesome dyskinesia. "Off" time refers to the periods of poor mobility, slowness and stiffness experienced by patients with Parkinson's disease.
The company said that the study was conducted to determine the efficacy, safety and tolerability of continuous LCIG infusion in patients with advanced Parkinson's disease compared to standard levodopa-carbidopa IR tablets. LCIG contains the same active medication as levodopa-carbidopa IR tablets but in gel form and is administered directly into the small intestine via a procedurally-implanted tube connected to a portable pump. At baseline, patients enrolled in the study had Parkinson's disease for an average of 10.9 years and experienced an average of 6.6 hours of "off" time a day.
Treatment-emergent adverse events (AE) occurred in 35 patients on LCIG (95 percent) and in 34 patients on levodopa-carbidopa IR tablets (100 percent) and were similar between the two treatment groups.
LCIG is an investigational therapy that is currently being evaluated in patients with advanced-stage Parkinson's disease in additional Phase 3 clinical trials in the U.S. It is approved in 40 countries outside the U.S.
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