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NeuroDerm Announces Positive Results of a Phase II Study of ND0611 Dermal Patch in Patients with Parkinson's Disease
Date:11/9/2011

>"One of our priorities at MJFF is to drive research that could improve the quality of life for people living with PD today," said Brian Fiske, PhD, director of research programs at MJFF.  "NeuroDerm is working to develop a therapy that might do just that.  By providing a more even and continuous supply of levodopa to the brain, ND0611 has the potential to limit the motor fluctuations that many patients experience during periods when their medication wears off."

"ND0611's remarkable success in its first phase I/II trial significantly raises the probability of it becoming a new treatment option for PD patients. ND0611 is unique: it is the first drug developed to administer carbidopa systemically; it acts directly on levodopa metabolism not only in the gastrointestinal tract; and it probably employs a different mode of action than orally administered carbidopa," said Oded S. Lieberman, PhD, NeuroDerm's Chairman and CEO. "ND0611 has now been shown to improve levodopa's bioavailability in patients with any type of oral levodopa drug used even improving the bioavailability of what is considered to be the best current levodopa oral therapy. One can now realistically hope that ND0611 may eventually establish a higher standard of care for PD patients undergoing oral LD therapy".

About the phase I/II Safety and Pharmacokinetic Study

This placebo controlled, randomized, double-blind, six-way crossover trial enrolled 24 patients with advanced Parkinson's disease. All patients were administered the three most commonly-used levodopa therapies (immediate-release Sinemet®, Sinemet®-CR, and Stalevo®) in 100mg dosage four times per day; in addition they received either ND0611 or placebo.

In addition to evaluating safety and tolerability, the study's primary endpoint was improvement in levodopa half life in all treatment arms; secondary endpoints included additional PK parameters. All PK parameters
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SOURCE NeuroDerm Ltd
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