NeuroDerm, a clinical stage pharmaceutical company focused on central nervous system (CNS) products, announced that the European Medicines Agency (EMA) pronounced eligibility of its Parkinson’s drug ND0612H for the European Union Centralized Procedure.
ND0612H is a high dose form of liquid levodopa/carbidopa (LD/CD) administered subcutaneously and continuously by a belt pump. The drug is intended to reduce the motor challenges that occur in the advanced stages of Parkinson’s disease through regular administration of high therapeutic levodopa plasma levels.
Dr. Oded Lieberman, NeuroDerm's CEO, said, “The eligibility for the centralized procedure in the European Union confirms the innovation underlying ND0612H… It also means that ND0612H will be able to benefit from the more streamlined access to the EU market inherent in this regulatory route.” Under its guidelines, the EMA can permit certain products to take the streamlined regulatory pathway if it considers them meaningful innovations, even if the products do not require centralized procedure for its MAA approval.
Last March, NeuroDerm reported the beginning of patient enrollment for the second Phase II trial of the drug. “This trial marks an important step in the development of ND0612 that could become a breakthrough treatment option for Parkinson's disease patients,” said Lieberman at the time.
The company reported that it has also completed Phase I and Phase IIA studies for the ND0612L, a low dose drug for patients with moderate stage Parkinson’s disease. NeuroDerm has been pushing the drug along in a Phase II placebo controlled trial with the help of a $1 million grant from The Michael J. Fox Foundation for Parkinson's Research, which it received last June.
Around 5 million across the world are affected by Parkinson’s disease, a disorder rooted in the progressive decrease of dopamine signaling in the brain due to the death of dopamigenic cells. According to the National Institute of Neurological Disorders and Stroke (NINDS), there is no approved cure for PD, though medications and, in some cases, deep brain stimulation (DBS) may be used to treat PD’s symptoms.