Depomed Reports Positive Results For Phase I Trial Of DM-1992

Depomed’s phase 1 pharmacokinetic study for DM-1992 has shown positive results, with an extended coverage above levodopa’s efficacious threshold and also extended the time to peak levodopa concentration relative.

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.

The phase I trial in DM-1992 was a randomized, open-label crossover study that enrolled 18 patients with stable Parkinson’s disease, at two neurology centers in Russia.

The objective of the study was 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.

Mike Sweeney, vice president of research and development at Depomed, said: “We are encouraged by the pharmacokinetic results observed in this study, as they indicate that DM-1992 may optimize the absorption of Levodopa in the duodenum, the area of the upper gastrointestinal tract where Levodopa is preferentially absorbed.

We have already begun work refining our formulation to optimize how our Acuform technology operates within stomachs of Parkinson’s patients, with a view to achieving a formulation that may be dosed twice daily with consistent efficacy and reduced side effects, which would represent a significant clinical benefit to Parkinson’s patients. After we complete further formulation work, we anticipate doing another phase I trial to confirm the performance of the formulation before out licensing the program,” he added.