Safety data on AbbVie’s ABBV-951 (foslevodopa/foscarbidopa) and NeuroDerm’s ND0612 (levodopa/carbidopa) for the treatment of Parkinson’s disease (PD) were showcased at the American Academy of Neurology (AAN) 2023 Annual Meeting. Should they receive FDA approval, these innovative levodopa delivery systems could offer an improved route of administration and will create additional options to control various motor complications in patients with advanced-stage PD. However, patient and caregiver education are important to improve patient outcomes, says GlobalData, a leading data and analytics company.

Christie Wong, Pharma Analyst at GlobalData, comments: “If approved, ND0612 and ABBV-951 could offer continuous subcutaneous infusion of levodopa. This is particularly important in patients with advanced-stage PD to achieve steady levodopa plasma concentration to control PD motor symptoms and avoid dyskinesia and off-episodes”

However, infusion-site reactions have been reported as a mild but common treatment-emergent adverse event associated with the subcutaneous infusion devices. In NeuroDerm’s three-year open-label extension study, 60.5% of patients had an infusion-site reaction during Year 1 of ND0612 treatment. But infusion-site reaction rates greatly diminished in Years 2 and 3 of the study.

Similarly, in AbbVie’s Phase III trial, when comparing the initial four-week optimization and the later eight-week maintenance periods of ABBV-951, a greater proportion of patients experienced infusion-site reactions during the optimization period.

Wong adds: “During the later stages of both studies, the rates of nodules and bruising at the infusion-site decreased. Investigators noted the initial higher rates of infusion-site reactions were due to acclimation to the new drug delivery systems. Furthermore, the decrease in infusion-site reactions could be attributed to patients becoming more adept in cleaning the infusion sites.”

Pivotal trials have demonstrated an improved motor symptom control with subcutaneous continuous levodopa infusions against oral levodopa therapy. However, a head-to-head comparing ABBV-951 and ND0612 does not appear to be on the horizon yet. The key opinion leaders (KOLs) previously interviewed by GlobalData noted that the administration of ND0612 required two injection entry points compared to AbbVie’s one. It is unknown whether the additional injection entry point with ND0612 sites could lead to a higher rate of infusion-site reactions.

Wong concludes: “Overall, KOLs were enthusiastic about the ability to control motor fluctuations and improve patients’ quality of life without the need for invasive surgery such as deep brain stimulation or installation of Duodopa. However, they emphasized that success of these levodopa infusion systems requires education programs for patients and caregivers to maintain these devices and avoid infusion-site reactions.”