Depomed, a specialty pharmaceutical company, has dosed the first patient in a Phase I trial for its DM-1992 program in Parkinson's disease based on positive results from preclinical studies sponsored by The Michael J Fox Foundation for Parkinson's Research.
The Phase I trial has been designed to compare pharmacokinetics in Parkinson’s patients of two formulations of DM-1992 and a generic version of Sinemet CR, a commercially available sustained release Levodopa/Carbidopa formulation.
The Phase I trial is a randomized, open-label crossover study designed to enroll 18 patients with stable Parkinson’s disease at two leading neurology centers in Russia. The objective of the study is to compare the pharmacokinetics of two distinct 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.
Patients in the trial will receive a single dose of each of the three treatments being studied. A dose of the first treatment will be administered at the beginning of the study, followed by a dose of a second treatment after seven to 14 days, and a dose of the third treatment after another seven to 14 days.
DM-1992 is an investigative novel gastric retentive extended-release dosage form of Levodopa/Carbidopa, a marketed therapy used in the treatment of Parkinson’s disease. Depomed top-line results from the trial are expected to be reported in the third quarter of 2009.
Carl Pelzel, president and CEO of Depomed, said: We believe our novel formulation of Levodopa/Carbidopa offers real clinical benefit and has the potential to positively impact the quality of life of Parkinson’s patients. On behalf of Depomed, I’d like to thank The Michael J Fox Foundation for its support of our preclinical studies in this area.