Subcutaneous Foslevodopa/Foscarbidopa Superior at Controlling Motor Fluctuations in Parkinson Disease

In a phase 3 clinical trial, continuous subcutaneous infusion of foslevodopa/foscarbidopa (fosLD/fosCD) (ABBV-951; Abbvie, Chicago, IL) was statistically superior to oral levodopa/carbidopa (LD/CD) at reducing motor fluctuations in participants with advanced Parkinson disease (PD). "On" time (hours) without troublesome dyskinesia (involuntary movements) increased after 12 weeks based on the Parkinson Disease Diary (PD Diary).

The "On" time at week 12 increased to 2.72 hours with fosLD/fosCD vs 0.97 hours with LD/CD (P= .0083). Improvements in "On" time were observed in the first week and remained consistent for 12 weeks. Hours of average daily normalized "Off" time were also reduced after the first week and through week 12 by 2.75 hours with fosLD/fosCD vs 0.96 hours with LD/CD (P=.0054).

"Patients need more therapeutic options to control their symptoms and troublesome dyskinesia for this debilitating disease," said Jason Aldred, MD FAAN of Selkirk Neurology, clinical associate professor at the University of Washington, clinical assistant professor at Washington State University Elson S. Floyd College of Medicine, and a principal investigator of the study. "These data are promising and demonstrate positive results on a key endpoint used to assess efficacy of treatments for patients with advanced Parkinson."

In the pivotal phase 3, randomized, double-blind, double-dummy, active-controlled study, majority of the adverse events (AEs) reported were nonserious and mild to moderate in severity in both groups. Incidence of serious AEs were 8% and 6% in the fosLD/fosCD and LD/CD groups, respectively. There was 1 participant with a treatment-emergent AE leading to death in the LD/CD group. The incidences of infusion site reactions and hallucination and psychosis were higher in the fosLD/fosCD group although most were nonserious and none led to systemic complications. Incidence of falls and associated injuries was lower in the fosLD/fosCD group compared to the oral LD/CD group. Treatment discontinuation occurred in 21.6% of participants treated with fosLD/fosCD vs 1.5% treated with LD/CD.