Depomed, Inc. has announced that in its second Phase 1 pharmacokinetic-pharmacodynamic study in Parkinson's patients, DM-1992, Depomed's investigative novel gastric-retentive, extended-release formulation of levodopa/carbidopa, maintained therapeutic blood levels of levodopa over 24 hours in a twice-daily formulation.
Two distinct twice-daily formulations of DM-1992 were tested in the study. Both 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 exceeded 300ng/mL. DM-1992 was well tolerated in the study.
"We believe DM-1992 may meet a significant unmet need of Parkinson's patients for a twice-daily formulation of levodopa/carbidopa that maintains therapeutic blood levels throughout the night, when the symptoms of Parkinson's disease can be particularly severe," said Carl Pelzel, Depomed's President and CEO. "We look forward to discussing further development of DM-1992 with potential collaborative partners," added Mr. Pelzel.
"We are pleased our reformulations of DM-1992 performed as we expected in Parkinson's patients. We believe we have product candidate ready to advance to Phase 2 clinical testing," said Dr. Mike Sweeney, vice president research and development of Depomed. "We would like to thank The Michael J. Fox Foundation for its support in funding a portion of the trial," added Dr. Sweeney.
The company expects to present the trial results at a scientific conference later this year.