Subcutaneous Foslevodopa/Foscarbidopa Enhances Sleep and QoL Synergistically in Parkinson Disease

Irene Malaty, MD

A post-hoc analysis from a 12-week, double-blind, active-controlled trial (NCT0438012) identified a significant correlation between sleep and quality of life (QoL) as well as between sleep and activities of daily living (ADL) in those with Parkinson disease (PD). In addition, findings showed supported a potential benefit of continuous subcutaneous infusion (CSCI) of foslevodopa/foscarbidopa (LDp/CDp; Vyalev; AbbVie) on sleep and QoL, although further studies are needed.¹

The analysis analyzed the number of sleep responders, assessed through PDSS-2, for those on oral levodopa/carbidopa immediate-release (LD/CD-IR) tablets (n = 67) vs LDp/CDp (n = 74). Presented at the 4th Annual Advanced Therapeutics in Movement and Related Disorders (ATMRD) Congress, held by the PMD Alliance from June 27-30, 2025, the analysis also looked at Patient Disease Questionnaire (PDQ-39) summary index, PDQ-39 subdomains, and ADL changes through Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part II score.

Led by Irene Malaty, MD, director of the Parkinson DiseaseFoundation Center Of Excellence And Tourette Association Of America Center For Excellence at the University of Florida, those in the oral LD/CD-IR group had least-square (LS) mean changes of –1.06 (SE, 0.79) in MDS-UPDRS Part II score, –2.52 (SE, 1.12) in PDSS-2 total score, and –2.28 (SE, 1.75) in PDQ-39 summary index score. In comparison, those in the LDp/CDp group demonstrated respective changes of –2.65 (SE, 0.82), –7.92 (SE, 1.18), and –6.38 (SE, 1.83).

In the analysis, Sleep Responders were considered those who had a clinically meaningful PDSS-2 total score improvement at least 3.44 points over the 12-week period. All told, there were significantly more sleep responders in the LDp/CDp group (72.7%; n = 32) than the oral LD/CD-IR treatment arm (42.4%; n = 25) during the active-controlled trial. Notably, the study found significant positive correlations between sleep scores on PDSS-2 and QoL or ADL after 12 weeks of treatment.

Data showed that Sleep Responders had significant improvements in QoL and ADL across the 12-week trial, with treatment differences favoring the LDp/CDp group. A closer look at the data revealed an LS mean treatment difference of –3.73 (SE, 2.78; 95% CI, –9.31 to 1.84) for PDQ-39 and –1.80 (SE, 1.41; 95% CI, –4.61 to 1.02) for ADL. The LDp/CDp group outperformed the oral group on specific PDQ-39 subdomains, including mobility (LS mean, –12.99 [SE, 3.10]), activities of daily living (–13.94 [SE, 3.81]), stigma (–12.39 [SE, 2.71]), communication (–8.01 [SE, 3.34]), and bodily discomfort (–13.28 [SE, 3.34]).

LDp/CDp, marketed under the name Vyalev, became the first and only subcutaneous 24-hour infusion of levodopa-based therapy approved for the treatment of motor fluctuations in PD in October 2024. Findings from the aforementioned phase 3, 12-week study, along with a 52-week open-label study supported the FDA’s decision to approve. In the original 12-week trial, patients treated with Vyalev gained an increase of 2.72 hours in good ON time without troublesome dyskinesia vs 0.97 hours for those on oral CD/LD-IR (P = .0083).²

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REFERENCES
1. Malaty I, Vaou EO, Hauser RA, et al. Correlation Between Sleep and Quality of Life in People With Parkinson Disease Treated with Continuous Subcutaneous Infusion of Foslevodopa/Foscarbidopa. Presented at: 2025 ATMRD Congress. June 27-30. Washington, D.C.
2. U.S. FDA Approves VYALEV™ (foscarbidopa and foslevodopa) for Adults Living with Advanced Parkinson's Disease. News release. AbbVie. October 17, 2024. Accessed June 27, 2025. https://news.abbvie.com/2024-10-17-U-S-FDA-Approves-VYALEV-TM-foscarbidopa-and-foslevodopa-for-Adults-Living-with-Advanced-Parkinsons-Disease