NeuroDerm commences ND0611 Phase I/II trial to treat Parkinson's disease

NeuroDerm, Ltd. announced today the enrollment of the first group of patients in its Phase I/II clinical trial of ND0611, a new patch for the treatment of Parkinson's disease. ND0611, a proprietary carbidopa liquid formula administered via a dermal patch, is designed to increase the bioavailability and efficacy of orally- administered levodopa and thus improve treatment of Parkinson's disease.

In pre-clinical studies, plasma concentrations of orally-administered levodopa showed markedly less fluctuation, higher area-under-the-curve values, and higher trough concentrations after continuous administration of ND0611 together with standard levodopa products (Sinemet(R), Stalevo(R) and Sinemet(R) CR). A phase I trial in young, healthy volunteers demonstrated that ND0611, co-administered with Sinemet(R), was safe and tolerable. It also showed that ND0611 increased levodopa clearance half-life, the duration of levodopa concentration in excess of a typical threshold for anti-Parkinsonian effect (1000ng/ml in plasma), and the area-under-the-concentration-time-curve of levodopa.


ClinicalTrials.gov: A Safety, Tolerability and Pharmacokinetic Study of ND0611 on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Parkinson's Disease Patients