NeuroDerm completes patient treatment in Phase iI trial of Parkinson's candidate
NeuroDerm completed patient enrollment and treatment in trial 006 of ND0612H, the company's continuously administered levodopa/carbidopa solution. ND0612H, administered subcutaneously through a belt pump, is designed to deliver steady LD/CD levels to advanced Parkinson's patients with motor fluctuations that cannot be adequately controlled with oral therapy and to become an alternative to treatments with surgical intervention. Trial 006 was the first trial to investigate the efficacy, safety, tolerability and pharmacokinetics of two dosing regimens of the high dose version of ND0612 compared with the baseline oral standard of care. Topline results from this trial are expected in 1Q17. ND0612 is designed to significantly reduce motor complications in Parkinson's disease patients through continuous, subcutaneous delivery of LD/CD solution. Previously completed Phase 2 trials demonstrated that a low dose of ND0612 maintained steady, therapeutic levodopa plasma concentrations that were associated with major changes in several clinical parameters including "off time" reductions when added to optimal oral standard of care.