FDA lifts clinical hold on ND0612H and ND0612L for the treatment of Parkinson’s disease

NeuroDerm has announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on U.S. clinical studies of ND0612H and ND0612L, the company’s primary product candidates for the treatment of Parkinson’s disease.

The hold was lifted after the FDA reviewed additional information related to the product candidates’ delivery devices. U.S. clinical development of these product candidates is therefore cleared to proceed in the second half of 2015.

“Having lifted the clinical hold in the first half of 2015 means that our U.S. clinical development programme of ND0612H and ND0612L is proceeding on track,” said Oded Lieberman, PhD, CEO of NeuroDerm. “Parkinson’s patients have been hoping for a less invasive, non-surgical alternative that can deliver levodopa continuously. We remain committed to the execution of our plan to bring these product candidates to the market as soon as possible, and to make a significant impact on the lives of Parkinson’s patients.”

NeuroDerm anticipates commencing several studies of ND0612H and ND0612L later in 2015

ND0612H and ND0612L are based on a proprietary, subcutaneously-delivered Levodopa/Carbidopa (LD/CD) liquid formulation. Oral administration of LD/CD is regarded as the “gold standard” treatment for patients suffering from Parkinson’s disease. Levodopa crosses into the brain and converts into dopamine to complement the reduced brain-dopamine levels. However, levodopa is limited by its short half-life. Approximately three to four hours after a single dose, almost none of the drug remains in the plasma and patients are required to take multiple LD/CD doses daily. ND0612H and ND0612L are designed to significantly reduce motor complications in Parkinson’s disease patients through continuous, subcutaneous delivery of LD/CD. 

In June 2014, the FDA placed a hold on the U.S. clinical development of ND0612H and ND0612L, requesting additional information on the accuracy, safety, and compatibility of the devices used to deliver the drug. The company completed the required compatibility study and submitted the requested additional information to the FDA. Following the FDA’s decision to lift the clinical hold, the company’s U.S. clinical development programme is now cleared to proceed, with several studies anticipated to commence in the second half of 2015.