The FDA has lifted the clinical hold on U.S. clinical studies of ND0612H and ND0612L, primary product candidates based on proprietary, subcutaneously-delivered Levodopa/Carbidopa (LD/CD) liquid formulation for the treatment of Parkinson's disease, owned by NeuroDerm, a clinical-stage pharmaceutical company developing drugs for central nervous system (CNS) diseases. 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 program of ND0612H and ND0612L is proceeding on track," said Oded Lieberman, Ph.D., 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."
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 program now is cleared to proceed, with several studies anticipated to commence in the second half of 2015.
Recently completed phase II trials demonstrated that ND0612L maintained steady, therapeutic levodopa plasma concentrations that were associated with major improvements in several clinical parameters including "off time" reductions when added to optimized oral standard of care. ND0612H, intended for severe Parkinson's disease patients, was shown to reach even higher levodopa steady plasma levels, indicating that it may provide an effective therapy alternative to current treatments requiring surgery such as deep brain stimulation and DuoDopa/Duopa.