Foslevodopa/foscarbidopa subcutaneous infusion maintains equivalent levodopa exposure to levodopa-carbidopa intestinal gel delivered to the jejunum. (April 2022)

• Record Type: Journal Article
• Authors: Rosebraugh, Matthew; Stodtmann, Sven; Liu, Wei; Facheris, Maurizio F.
• Is Part Of: Parkinsonism & related disorders. Volume 97(2022)
• Page Start: 68
• Page End: 72
• Publication Date: 2022-04
• Subjects: Levodopa -- Carbidopa -- Parkinson's disease -- Pharmacokinetics; Parkinson's disease -- Periodicals; Movement disorders -- Periodicals; Movement Disorders -- Periodicals; Nerve Degeneration -- Periodicals; Nervous System Diseases -- Periodicals; Parkinson Disease -- Periodicals; Tremor -- Periodicals; Parkinson, Maladie de -- Périodiques; Parkinson's disease; 616.833
• DOI: 10.1016/j.parkreldis.2022.03.012
• Languages: English
• ISSNs: 1353-8020

Abstract

Abstract: Introduction: The objective of this study was to compare the pharmacokinetics (PK) of levodopa (LD) from 24-h continuous subcutaneous infusion of foslevodopa/foscarbidopa to the LD pharmacokinetics from 16-h levodopa-carbidopa intestinal gel (LCIG) followed by night-time oral LD/carbidopa (CD) doses. Methods: This was a Phase 1, open-label, randomized, 2-period crossover study conducted in 25 male and female healthy volunteers. Results: The LD exposures (Cmax0-16, AUC0-16 and AUC∞) following subcutaneous infusion of 700/35 mg foslevodopa/foscarbidopa over 24 h were similar (<8% difference) to those of LCIG 350/87.5 mg LD/CD administered over 16 h followed by two 100/25 mg LD/CD oral doses at 18 and 21 h after the start of LCIG delivery. Conclusion: Foslevodopa/foscarbidopa subcutaneous infusion provides levodopa exposures comparable to LCIG throughout the day. ClinicalTrials.gov identifier: Not Applicable. Highlights: Foslevodopa/foscarbidopa LD exposures are comparable to LCIG in healthy volunteers. LD degree of fluctuation was low for foslevodopa/foscarbidopa infusion and LCIG. Foslevodopa/foscarbidopa maintains LD exposure within a narrow therapeutic window.