Poster Presentation Australian and New Zealand Society for Geriatric Medicine Annual Scientific Meeting 2025

A Post Hoc Efficacy Analysis of Phase 3 Trials of Continuous Subcutaneous Foslevodopa/Foscarbidopa in Patients With Parkinson’s Disease (120032)

Michael J Soileau 1 , Manon Bouchard 2 , Irene A Malaty 3 , Juan Carlos Parra 4 , Lars Bergmann 4 , Resmi Gupta 4 , Amy Spiegel 4 , Jenny Waern 5 6 , Eric Freire-Alvarez 7
  1. Texas Movement Disorder Specialists, Georgetown, Texas, United States
  2. Clinique Neuro-Lévis, Lévis, Quebec, Canada
  3. Department of Neurology, man Fixel Institute for Neurological Diseases, University of Florida College of Medicine, Gainesville, Florida, United States
  4. AbbVie Inc., North Chicago, Illinois, United States
  5. AbbVie Pty Ltd, Mascot, NSW, Australia
  6. This individual has been added to this publication author by-line, with the permission of the original authors, for the express purpose of conducting the presentation at a local congress or in a local language. , He/she did not contribute to the content of the publication.
  7. Neurology Department, University General Hospital of Elche, Carrer Almazara, Elche, Spain

Aim: To further evaluate the efficacy of foslevodopa/foscarbidopa (LDp/CDp), a soluble formulation of levodopa/carbidopa (LD/CD) prodrugs delivered continuous subcutaneous infusion, for people with advanced Parkinson’s disease (PwaPD).

 

Methods: PwaPD with ≥ 2.5 hours “Off” time/day were enrolled in 2 phase 3 trials investigating LDp/CDp [1, 2]. PwaPD were randomized 1:1 to LDp/CDp or oral immediate-release (IR) LD/CD in the 12-week double-blind study (NCT04380142) [2]; in the 52-week study all PwaPD received open-label LDp/CDp (NCT03781167) [2]. Effect size, NNT, and change from baseline (BL) were evaluated post hoc for “Off”/“On” times, daily activities (MDS-UPDRS Part II), sleep (PDSS-2), and quality of life (PDQ-39).

 

Results: This analysis includes 141 PwaPD from the 12-week study, and 244 PwaPD (LDp/CDp) from the 52-week study. Within-group effect size showed a benefit of LDp/CDp vs oral IR LD/CD at week 12 for reduction in “Off” time (–0.7 vs –0.3) and improvements in “On” time without troublesome dyskinesia (0.7 vs 0.2. At week 12, the NNT for minimum clinically important differences in “Off” time (reduced ≥ 1 hour) and “On” time without troublesome dyskinesia (improved ≥ 1 hour) was lower with LDp/CDp (1.5 and 1.6) vs oral IR LD/CD (2.5 and 2.4).

 

Conclusions: In PwaPD, LDp/CDp demonstrated improved motor function, daily activities, sleep, and quality of life vs PwaPD on oral IR LD/CD when assessed by effect size, NNT, and percent change from BL.

  1. Soileau MJ, et al. Lancet Neurol. 2022;21:1099–1109
  2. Aldred J, et al. Neurol Ther. 2023;12:1937–1958