Directly infused levodopa intestinal gel was shown to be more effective than standard oral therapy.
Abbott reported positive data from a U.S. Phase III study evaluating its Parkinson disease candidate, levodopa-carbidopa intestinal gel (LCIG). The product, which has already been approved in 40 non-U.S. markets, comprises the same active drug as levodopa-carbidopa immediate release (IR) tablets, but in a gel formulation that is administered directly into the small intestine via an implanted tube connected to a portable pump.
Data from the reported Phase III study showed that LCIG led to clinically meaningful and statistically significant improvements in “off” time without increases in dyskinesia, when compared with treatment using levodopa-carbidopa IR tablets. Specifically, LCIG patients experienced on average 1.91 fewer off time hours per day (i.e., a 4-hour decrease in off time from baseline) than those receiving the tablet therapy and 1.86 hours more “on” time (an improvement of 4.1 hours from baseline) than tablet-treated patients. Enrolled patients had been Parkinson disease sufferers for an average of 10.9 years at baseline, and experienced an average of 6.6 hours of off time per day.