NeuroDerm has reported the results of a phase I/II safety and pharmacokinetic trial of ND0611, administered as an adjunct therapy to Sinemet-CR, Sinemet or Stalevo, in patients with advanced Parkinson's disease. ND0611 is a proprietary carbidopa liquid formula administered sub-cutaneously via a dermal patch to increase the bioavailability and efficacy of orally- administered levodopa. Results of this study support the continued development of ND0611 for the treatment of Parkinson's disease.
This double-blind, randomized, six-way crossover study met all of its primary and secondary endpoints. The analysis showed that ND0611, when compared with placebo, showed meaningful, highly statistically significant improvement in all of the pharmacokinetic endpoints when administered with three most common oral levodopa therapies (immediate-release Sinemet, Sinemet-CR, and Stalevo). The primary and secondary PK endpoints included levodopa half-life, the duration of levodopa concentration in excess of a threshold of 1000ng/ml in plasma, the area-under-the-concentration-time-curve and evodopa trough levels.
The most common adverse events across all treatment arms, including placebo, were vertigo, nausea, asthenia, back pain, myalgia, pain in extremity, headache and erythema. There were no clinically relevant effects seen in laboratory measured or vital signs.
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.
The study's primary endpoint was improvement in levodopa half life in all treatment arms; secondary endpoints included additional PK parameters. All PK parameters for each oral treatment mode were evaluated separately and showed statistical significance.