Results from a phase 2 clinical trial (NCT02605434) show that administration of levodopa/carbidopa (LD/CD) with a unique delivery system (Accordion pill [AP]; Intec Pharma, Jerusalem, Israel) improved advanced Parkinson’s disease (PD) with participants’ current treatment. This drug delivery system is designed to improve efficacy and safety through a gastric retention and a pill with multilayer films containing immediate-release carbidopa (CD) and immediate- and controlled-release LD. This formulation is designed to improve the consistency of LD release into the bloodstream to offering patients more consistent symptom management.
The multicenter, randomized study, published in Parkinsonism and Related Disorders, evaluated pharmacokinetics and efficacy of the new drug delivery system compared with immediate release LD/CD.
Results of pharmacokinetic studies showed that treatment with the new drug delivery system produced more stable LD plasma levels for participants with or without motor fluctuations compared with treatment with immediate-release LD/CD. The LD Cmax was significantly reduced with the new drug delivery system (by 57.1% and 66.8% in in those with and without motor fluctuations, respectively) compared with immediate-release LD/CD.
Treatment with the new drug delivery system also significantly improved patient and investigator ratings on the Global Clinical Impression scale compared with current treatment (P < 0.01).
"In addition to more consistent LD plasma concentrations with the Accordion pill, regardless of whether patients were experiencing motor fluctuations, this new delivery platform resulted in decreased OFF time compared with the IR form,” said Peter A. LeWitt, MD, departments of neurology, Henry Ford Hospital and Wayne State University School of Medicine. “Importantly, the substantially improved ON time for the Accordion pill versus IR was attained without an emergence of troublesome dyskinesia."
Marc Nuwer, MD, PhD
Melissa Reider-Demer, DNP, MN, CNP; and Vishal Shah, MD
Swarna Rajagopalan, MD