Depomed reports positive Parkinson’s drug study results
PBR Staff Writer Published 10 February 2011
Depomed has reported positive results from its second Phase 1 trial which evaluated DM-1992, its investigative extended-release formulation of levodopa/carbidopa in patients with Parkinson’s disease.
The study results showed that two distinct twice-daily formulations of DM-1992 maintained therapeutic blood levels of levodopa over 24 hours, Depomed said.
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.