ND0612L is expected to be used to treat moderate stage Parkinson’s disease patients who can no longer effectively control their motor complications with oral levodopa. ND0612L can be continuously administered, as a fixed dose, over a 24-hour (day and night) period. By maintaining steady plasma levodopa concentrations, ND0612L should significantly improve motor and non-motor complications, including dyskinesia and “off” periods. ND0612L is administered subcutaneously through a convenient, small belt-worn pump similar to the administration devices used to deliver insulin to diabetic patients. A second generation product, using a patch pump to deliver LD/CD, is under development.
ND0612L belt pump version
24-hour, subcutaneous administration via a convenient, small belt-pump.
ND0612L Patch Pump Version
24-hour, subcutaneous administration via a convenient, discreet patch pump.
Previous clinical studies with N0612L included two phase I studies and a Phase IIa, single-dose, 24-hour continuous-administration, randomized, double-blind, placebo-controlled study on eight subjects with moderate Parkinson’s disease. Results showed that subcutaneous delivery of ND0612L was safe and tolerable, and achieved steady-state plasma levodopa concentrations of 700-900 ng/ml (which is estimated to be within the typical therapeutic range). Additionally, administration of ND0612L was shown to significantly reduce fluctuations in plasma levodopa concentrations.
In 2014, NeuroDerm completed a Phase II randomized, placebo-controlled, double-blind study of ND0612L on 30 Parkinson’s disease patients suffering from motor complications. The study’s primary endpoints were safety and tolerability, as well as the pharmacokinetic profile of levodopa plasma concentrations. Exploratory clinical efficacy endpoints were also followed. Final results of this phase II study showed that patients with moderate to severe Parkinson’s disease who received continuous, subcutaneous doses of ND0612L exhibited clinically significant reduction in fluctuations of plasma levodopa concentrations compared to patients receiving placebo. Patients receiving ND0612L also experienced a corresponding in-clinic two-hour reduction over placebo in “off” time, improved sleep, better quality of life and global clinical improvement without an increase in troublesome dyskinesia.