NeuroDerm announced on 4 March 2013, the results of a phase I safety and pharmacokinetic trial of ND0612, a novel drug formulation for the treatment of Parkinson’s disease. ND0612 is a proprietary levodopa/carbidopa liquid formula administered continuously subcutaneously through a patch pump. It is designed to provide steady levodopa blood levels for the reduction of motor complications in Parkinson’s disease. Results of this study support the continued development of ND0612 for the treatment of Parkinson’s disease.
In this double-blind, placebo controlled, dose-escalation trial in young, healthy volunteers, ND0612 was shown to be safe and tolerable in all of the tested doses, according to a press release. Furthermore, clinically meaningful levodopa concentrations were reached and, for the first time in man, steady state levodopa concentrations were maintained in a practical manner both day and night. The full results of this study will be presented at a future scientific meeting.
“ND0612’s success in its first phase I trial means that clinically significant steady state levodopa concentrations can, for the first time, be maintained, both day and night, through a conveniently administered drug. With ND0612, steady state levodopa levels, the elusive holy grail of Parkinson’s levodopa therapy, should be available to all Parkinson’s disease patients. Moreover, as ND0612 bypasses the gastrointestinal tract, steady state levodopa levels should be little influenced by intestinal absorption or oral ingestion of food or drugs. We believe that ND0612 could become a breakthrough treatment option that may establish a new, significantly higher standard of care for Parkinson’s patients.”
According to the company, ND0612 is a proprietary formulation of levodopa and carbidopa administered through a pump patch that enables convenient and steady state levodopa plasma levels. Levodopa and carbidopa (traditionally co-administered with levodopa to prevent its breakdown) are nearly always administered orally and have an unfavourable pharmacokinetic profile due to short half life and low bioavailability. Continuous subcutaneous delivery of levodopa and carbidopa is a novel approach designed to improve their pharmacokinetic profile and maintain stable, therapeutic levodopa plasma concentrations, thereby significantly ameliorating motor fluctuations and non-motor complications in Parkinson’s disease.