NeuroDerm out of Rehovot, Israel has announced that its system for delivery of levodopa/carbidopa for treatment of Parkinson’s disease is now eligible for the EU marketing authorization application procedure, aka centralized procedure. This means that the company streamlined the process for all European markets, helping to move the product forward toward approval.
ND0612H delivers a high-dose of evodopa/carbidopa in a liquid form subcutaneously via a pump attached at the belt, a route that’s expected to overcome some of the poor pharmacokinetics associated with oral administration of the drugs. The hope is that this treatment will maintain more consistent levels of levodopa plasma and so help reduce motor symptoms of patients with advanced Parkinson’s. The treatment has gone through Phase I and IIa clinical trials and is currently moving through a Phase II double-blind, randomized, placebo-controlled study.
Product page: ND0612H…
Press release: NeuroDerm Announces Eligibility for European Union Centralized Procedure for ND0612H…