Depomed, Inc. (NASDAQ:DEPO) today announced that in its Phase 1 pharmacokinetic study in Parkinson’s patients, DM-1992, Depomed’s investigative novel gastric retentive extended-release formulation of levodopa/carbidopa, extended coverage above levodopa’s efficacious threshold and extended the time to peak levodopa concentration relative to currently available sustained release levodopa/carbidopa formulations.
One of Depomed’s formulations in the study extended the median time point at which levodopa blood levels exceeded the efficacious threshold of 300 ng/mL to approximately nine hours, compared to approximately seven hours for the generic version of Sinemet CR tested in the study. The time to median peak levodopa blood levels in the study was extended to four hours, compared to 2.8 hours for the comparator. DM-1992 was well tolerated in the study.
“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,” said Dr. Mike Sweeney, vice president research and development of Depomed. “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,” added Dr. Sweeney.
“Depomed’s technology was able to significantly extend the duration of plasma levels of levodopa/carbidopa. The Phase 1 clinical data was very encouraging and we look forward to further work to perfect this formulation in the clinic,” added Dr. Igor Stolyarov MD, PhD, Doctor of Medical Sciences, Professor at Institution of Russian Academy of Sciences “Institute of Human Brain of RAS", one of the two principal investigators in the study with Professor Sergey Illarioshkin from St Petersburg.
DM-1992 Phase I Trial Design