Depomed has reported positive results from the second Phase I trial of DM-1992, its investigative gastric-retentive, extended-release formulation of levodopa / carbidopa in patients with Parkinson’s disease.
The study demonstrated that two distinct twice-daily formulations of DM-1992 maintained therapeutic blood levels of levodopa over 24 hours.
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Both the formulations are projected, at steady state, to consistently maintain levodopa blood levels above the efficacious threshold of 300ng/mL for 24 hours, as mean levodopa blood levels after 24 hours were above 300ng/mL.
DM-1992 was well-tolerated in the study.
The randomised, open-label crossover study enrolled 16 patients with stable Parkinson’s disease at two neurology centres in Russia.
The study was designed to compare the pharmacokinetics-pharmacodynamics of two distinct twice-daily formulations of DM-1992 and a generic version of Sinemet CR sustained-release levodopa / carbidopa, as well as the safety and tolerability of the formulations.
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