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FDA lifts clinical hold on NeuroDerm's ND0612 to treat Parkinson's disease

Monday May 11, 2015

PBR Staff Writer

Pharmaceutical Business Review - The US Food and Drug Administration (FDA) has lifted the clinical hold on Israeli pharmaceutical firm NeuroDerm's US clinical studies of its primary product candidates, ND0612H and ND0612L, which are based on proprietary, subcutaneously-delivered Levodopa/Carbidopa (LD/CD) liquid formulation, to treat Parkinson's disease.

The agency lifted the clinical hold after reviewing additional information related to the product candidates' delivery devices.

The company said that the US clinical development of these product candidates is now cleared to proceed in the second half of this year.

NeuroDerm CEO Oded Lieberman said: "Having lifted the clinical hold in the first half of 2015 means that our US clinical development program of ND0612H and ND0612L is proceeding on track.

"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."

In June last year, the FDA placed a hold on the US clinical development of ND0612H and ND0612L, requesting additional information on the accuracy, safety, and compatibility of the devices used to deliver the drug.

Both ND0612H and ND0612L are designed to significantly reduce motor complications in Parkinson's disease patients through continuous, subcutaneous delivery of LD/CD.

http://www.pharmaceutical-business-review.com/news/fda-lifts-clinical-hold-on-neuroderms-nd0612-to-treat-parkinsons-disease-110515-4573446