Abstract
An enteral suspension (ES)/intestinal gel formulation of levodopa/carbidopa (hereafter referred to as levodopa/carbidopa ES) [Duodopa® (EU); Duopa™ (USA)] has been developed to overcome the fluctuating plasma levodopa concentrations associated with oral levodopa/carbidopa formulations. In various countries, including those of the EU (under the Mutual Recognition Procedure), it is approved for the treatment of advanced levodopa-responsive Parkinson’s disease (PD) with severe motor fluctuations and hyperkinesia or dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results. In several other countries, including the USA, it is approved for the treatment of motor fluctuations in patients with advanced PD. In adults with advanced PD, levodopa/carbidopa ES improved motor fluctuations, activities of daily living and health-related quality of life (HR-QOL) during short-term (12-week) treatment, with the beneficial effects on motor fluctuations largely sustained over the longer term (up to 7 years). Levodopa/carbidopa ES was generally well tolerated in this patient population, with adverse events (AEs) associated with aging, advanced PD-related comorbidities, the procedure/device or dopaminergic therapy. Its safety profile was comparable to that of oral levodopa/carbidopa with respect to non-procedure/device-associated AEs; most procedure/device-associated AEs were consistent in nature and incidence with medically recognised complications of the procedure in non-PD patients. Current evidence indicates that levodopa/carbidopa ES is an effective and generally well tolerated option for the treatment of motor fluctuations in patients with levodopa-responsive advanced PD who are not being effectively managed with non-invasive therapies.
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During the peer review process, the manufacturer of levodopa/carbidopa enteral suspension was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.
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The preparation of this review was not supported by any external funding.
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Sheridan Hoy is a salaried employee of Adis International Ltd/Springer Nature, is responsible for the article content and declares no relevant conflicts of interest.
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Enhanced material for this Adis Drug Evaluation can be found at https://doi.org/10.6084/m9.figshare.9794693.
The manuscript was reviewed by:J. H. Friedman, Butler Hospital, Warren Alpert Medical School of Brown University, Providence, RI, USA; K. Jellinger, Institute of Clinical Neurobiology, Vienna, Austria; C. Sampaio, CHDI Management/CHDI Foundation, Princeton, NJ, USA and Clinical Pharmacology Lab, Faculdade de Medicina de Lisboa, University of Lisbon, Lisbon, Portugal; J. T. Slevin, Department of Neurology, University of Kentucky Medical Center, Lexington, KY, USA.
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Hoy, S.M. Levodopa/Carbidopa Enteral Suspension: A Review in Advanced Parkinson’s Disease. Drugs 79, 1709–1718 (2019). https://doi.org/10.1007/s40265-019-01201-1
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DOI: https://doi.org/10.1007/s40265-019-01201-1