Bioequivalence of Foslevodopa/Foscarbidopa continuous subcutaneous infusion to arm, thigh, or flank versus abdomen in healthy and advanced Parkinson’s disease individuals

Sep 29, 2026

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Foslevodopa/foscarbidopa (LDp/CDp) are soluble prodrugs of levodopa/carbidopa delivered as continuous subcutaneous infusion (CSCI) via a portable pump to provide continuous levodopa exposure. Safety and relative bioavailability were evaluated after 24-hour CSCI to the arm, thigh, and flank versus the abdomen in healthy volunteers and adults with advanced Parkinson’s disease. Two open-label randomized crossover studies assessed pharmacokinetics, and the 90% confidence intervals for AUC and Cmax met bioequivalence criteria. Mild infusion site reactions were most common, with no serious events or early discontinuations.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages7

Reading Time18 min

AccessFree to download

Introduction

Background on oral levodopa and carbidopa

Rationale for alternate infusion delivery systems

Methods

Study design in healthy volunteers and advanced Parkinson’s disease

Infusion sites and dosing schedule

Results

Bioequivalence of exposure measures (AUC and Cmax)

Safety and treatment-emergent adverse events

Conclusions

PRDOA 13 (2025) 100359 Contents lists available at ScienceDirect Clinical Parkinsonism & Related Disorders journal [homepage:](homepage: www.sciencedirect.com/journal/clinical-parkinsonism-and-related-disorders)[ www.sciencedirect.com/journal/clinical-parkinsonism-and-related-disorders](homepage: www.sciencedirect.com/journal/clinical-parkinsonism-and-related-disorders) | Bioequivalence of Foslevodopa/Foscarbidopa continuous subcutaneous infusion to arm, thigh, or flank versus abdomen in healthy and advanced Parkinson’s disease individuals | | | | | --- | --- | --- | --- | | Yi Rang Hana,*, Anna Jeong a, Kanwal Ayub a, Shelly V. Gupta a, Lars Bergmanna, Drew S. Kern b, Fernando Pagan c, Matthew Rosebraugha
a AbbVie, Inc., North Chicago, IL, USA
b Departments of Neurology and Neurosurgery, University of Colorado School of Medicine, Aurora, CO, USAc Movement Disorders Clinic, Department of Neurology, MedStar Georgetown University Hospital, Washington, DC, USA | | | | | A R T I C L E I N F O | | A B S T R A C T | | | Keywords: Levodopa Carbidopa
Advanced Parkinson’s disease
Subcutaneous infusions Pharmacokinetics Prodrugs Bioequivalence Bioavailability Subcutaneous levodopa Infusion therapies | | Background: Foslevodopa/foscarbidopa (LDp/CDp) are soluble prodrugs of levodopa/carbidopa delivered as a continuous subcutaneous infusion (CSCI) via a portable pump to provide continuous levodopa exposures. Objective: To assess the safety of LDp/CDp and the relative bioavailability of levodopa/carbidopa following LDp/ CDp 24-hour CSCI administration to the arm, thigh, and flank versus the abdomen.
Methods: Two open-label, randomized crossover studies (healthy adult volunteers [HV]; adults with advanced Parkinson’s disease [aPD]; NCT05094050) evaluated 24-hr CSCI of LDp/CDp to different infusion sites (abdomen, arm, thigh, flank), each designated as a study regimen. Participants in the aPD study had levodoparesponsive idiopathic Parkinson’s disease with ≥2.5 h of “Off” time/day. In the HV study, each LDp/CDp regimen was administered over 24 h, with 72-hour washout periods between regimens. In the aPD study, LDp/ CDp was administered for 2 consecutive days at each infusion site, with no washout between regimens. Results: For both levodopa and carbidopa, the 90% confidence intervals for both exposure measures (AUC and C max) were within the 80–125% range for the comparison between the abdomen and each alternate infusion site, meeting the criteria for bioequivalence. The most commonly reported treatment-emergent adverse events (TEAEs) were mild infusion site reactions, which occurred in 3/12 participants (HV study) and 9/16 participants (aPD study). There were no serious TEAEs and no event led to early discontinuation in either study. Conclusions: The pharmacokinetics of levodopa and carbidopa demonstrated that the abdomen, arm, thigh, and flank are interchangeable sites for CSCI of LDp/CDp. There were no concerning patterns of adverse events. | | 1. Introduction Dopamine replacement with oral levodopa preparations is the mainstay of treatment for Parkinson’s disease (PD) [1,2]. These standard levodopa preparations are typically co-administered with oral carbidopa, an aromatic amino acid decarboxylase inhibitor that minimizes the peripheral conversion of levodopa to dopamine [1,3], thus enhancing the amount of levodopa available to cross the blood brain barrier, where it is converted into dopamine [1,3–5]. Neither dopamine nor carbidopa crosses the blood brain barrier [4]. There is currently no cure or disease modifying agent available for the management of PD [6]. Thus, the therapeutical goal of PD treatment is symptomatic relief and improving quality of life [1]. As PD worsens from its early stages to advanced disease, a combination of progressive nigrostriatal dopaminergic denervation and unreliable absorption of oral levodopa medications may lead to disabling motor and non-motor symptoms [5,7]. Para

FAQs

What was the primary objective of the studies?

To assess the safety of LDp/CDp and the relative bioavailability of levodopa/carbidopa after 24-hour CSCI delivered to the arm, thigh, and flank versus the abdomen.

How were the pharmacokinetic comparisons performed across infusion sites?

Two open-label randomized crossover studies evaluated 24-hour CSCI regimens at different sites. Bioequivalence was concluded when 90% confidence intervals for AUC and Cmax fell within the 80–125% range for abdomen versus each alternate site.

What adverse events were most commonly reported?

The most commonly reported treatment-emergent adverse events were mild infusion site reactions, occurring in 3/12 participants in the healthy volunteer study and 9/16 in the advanced Parkinson’s disease study.

Did the study identify any serious safety concerns or early discontinuations?

No serious treatment-emergent adverse events were reported, and no event led to early discontinuation in either study.

Sep 29, 2026

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