Israeli pharma company NeuroDerm Ltd. tells us that the European Medicines Agency (EMA) has given the nod to one of its Parkinsons disease therapies. So-called ND0612H is a product candidate offering continuous delivery of levodopa/carbidopa (LD/CD) for advanced Parkinson’s disease and has been deemed eligible for a European Union marketing authorization application procedure (“centralized procedure”). The EMA can allow products for which the centralized procedure is not mandatory to use that procedure, if the EMA considers that it constitutes a significant therapeutic, scientific or technical innovation.
NeuroDerm has two product candidate, so-called ND0612L and ND0612H, which it says are the first liquid formulations of levodopa and carbidopa to be administered subcutaneously to conveniently achieve steady state levodopa plasma levels, thereby avoiding the pitfalls of traditional oral administration.
ND0612H is a high-dose form of liquid LD/CD drug delivered continuously through subcutaneous administration by a belt pump. ND0612H is designed to significantly reduce motor complications in advanced Parkinson’s disease patients by maintaining steady, high levodopa plasma levels in a convenient manner, to replace current treatments that require highly invasive surgery associated with serious side effects.
ND0612L, NeuroDerm’s low dose drug form for moderate stage Parkinson’s patients, has successfully completed Phase I and IIa studies. It is currently undergoing a Phase II double-blind, randomized, placebo-controlled study supported by a grant from The Michael J. Fox Foundation for Parkinson’s Research.
“The eligibility for the centralized procedure in the European Union confirms the innovation underlying ND0612H,” said Oded Lieberman, PhD, NeuroDerm’s CEO. “It also means that ND0612H will be able to benefit from the more streamlined access to the EU market inherent in this regulatory route. NeuroDerm wishes to bring ND0612H into the market as quickly as possible and make a dramatic change in the lives of Parkinson’s disease patients.”
Source: NeruoDerm Ltd.