Israel-based pharmaceutical company NeuroDerm has reported positive results from a double-blind, placebo controlled, dose-escalation Phase I study of its levodopa / carbidopa liquid formula for the treatment of Parkinson’s disease.
Administered continuously sub-cutaneously through a patch pump, the ND0612 formula is designed to improve pharmacokinetic profile, maintain stable therapeutic levodopa plasma concentrations and ameliorate motor fluctuations and non-motor complications in Parkinson’s disease.
The pharmacokinetic trial conducted in young, healthy volunteers, had shown ND0612 to be safe and tolerable in all of the tested doses.
NeuroDerm said success in its first Phase I trial means that clinically significant steady state levodopa concentrations can, for the first time, be maintained in a practical manner both day and night.
"With ND0612, steady state levodopa levels, the elusive holy grail of Parkinson’s levodopa therapy, should be available to all PD patients," the company said.
"Moreover, as ND0612 bypasses the gastrointestinal tract, steady state levodopa levels should be little influenced by intestinal absorption or oral ingestion of food or drugs."
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The company’s products also include ND0611 for the treatment of Parkinson’s disease and ND0801, a combination patch, for the treatment of attention deficit disorder (ADD) / attention deficit hyperactivity disorder (ADHD).
The company said that its programmes focused on other diseases, including schizophrenia and Alzheimer’s disease, are in different stages of development.