@article{c11bfcb9362a4e12b5981d4dfa7b5176,
title = "Subcutaneous Levodopa Infusion for Parkinson's Disease: 1-Year Data from the Open-Label BeyoND Study",
abstract = "Background: Continuous, subcutaneous (SC) levodopa/carbidopa infusion with ND0612 is under development as a treatment for patients with Parkinson's disease (PD) and motor fluctuations. Objective: Evaluate 1-year safety data. Methods: BeyoND is an open-label study evaluating the long-term safety of two ND0612 dosing regimens. Results: Of the 214 enrolled patients (24-hour SC infusion: n = 90; 16-hour SC infusion: n = 124), 120 (56%) completed 12 months of treatment. Leading causes for study discontinuation were consent withdrawal (19.6%) and adverse events (17.3%). Rates of discontinuation were reduced from 49% to 29% after a protocol revision and retraining. Systemic safety was typical for PD patients treated with levodopa/carbidopa. Most patients experienced infusion site reactions, particularly nodules (30.8%) and hematoma (25.2%), which were judged mostly mild to moderate and led to discontinuation in only 10.3% of the participants. Conclusions: Subcutaneous levodopa/carbidopa continuous infusion with ND0612 is generally safe, with typical infusion site reactions for SC delivery as the main adverse event.",
keywords = "ND0612, Parkinson's disease, infusion, levodopa, safety, subcutaneous",
author = "{and for the BeyoND study group} and Werner Poewe and Fabrizio Stocchi and David Arkadir and Georg Ebersbach and Ellenbogen, {Aaron L.} and Nir Giladi and Isaacson, {Stuart H.} and Karl Kieburtz and Peter LeWitt and Olanow, {C. Warren} and Tanya Simuni and Astrid Thomas and Abraham Zlotogorski and Liat Adar and Ryan Case and Sheila Oren and {Fuchs Orenbach}, Shir and Olivia Rosenfeld and Nissim Sasson and Tami Yardeni and Espay, {Alberto J.}",
note = "Funding Information: This study was sponsored by NeuroDerm Ltd. Funding agency: Funding Information: W.P. reports receiving personal fees from AbbVie, AFFiRiS, AstraZeneca, BIAL, Boston Scientific, Britannia, Intec, Ipsen, Lundbeck, NeuroDerm, Neurocrine, Denali Pharmaceuticals, Novartis, Orion Pharma, Prexton, Teva, UCB, and Zambon. He receives royalties from Thieme, Wiley Blackwell, Oxford University Press, and Cambridge University Press and grant support from The Michael J. Fox Foundation, EU FP7, and Horizon 2020. F.S. reports honoraria and consulting fees from Britannia Pharmaceuticals, GlaxoSmithKline, Boehringer Ingelheim, Lundbeck, Orion, Novartis, Teva, Pfizer, and Zambon. A.Z. reports fees for consultancy from NeuroDerm Ltd. D.A. has no financial interests to disclose. G.E. reports advisory roles for AbbVie, BIAL, Biogen GmbH, Desitin Pharma, STADA Pharma, and Neuroderm; lecture fees for AbbVie, BIAL, Britannia, Desitin Pharma, Licher GmbH, UCB Pharma, and Zambon Pharma and royalties from Kohlhammer Verlag and Thieme Verlag. A.L.E. reports honoraria and consulting fees from Allergan, Ipsen, Revance, Lundbeck, Affiris, Acorda, Kyowa, Biohaven, Teva, and Adamas. N.G. serves as consultant to Sionara, NeuroDerm, Pharma2B, Denali, Neuron23 and Abbvie, Sanofi‐Genzyme, and Biogen. He receives royalties from Lysosomal Therapeutics (LTI) and payment for lectures at Abbvie, Sanofi‐Genzyme, and the Movement Disorder Society. He received research support from The Michael J. Fox Foundation, the National Parkinson Foundation, the European Union, and the Israel Science Foundation as well as from Teva NNE program, Biogen, and Ionis. He receives support from the Sieratzki Family Foundation and the Aufzien Academic Center in Tel‐Aviv University. S.H.I. reports honoraria for CME, consultant, research grants, and/or promotional speaker on behalf of Abbvie, Acadia, Acorda, Adamas, Addex, Affiris, Alexva, Allergan, Amarantus, Amneal, Aptinyx, Axial, Axovant, Benevolent, Biogen, Britannia, Cadent, Cala, Cerecor, Cerevel, Cipla, Eli Lilly, Enterin, GE Healthcare, Global Kinetics, Impax, Impel, Intec Pharma, Ipsen, Jazz, Kyowa, Lundbeck, Merz, The Michael J. Fox Foundation, Mitsubishi Tanabe, Neuralys, Neurocrine, Neuroderm, Parkinson Study Group, Pharma2B, Prilenia, Promentis, Revance, Roche, Sanofi, Sunovion, Sun Pharma, Supernus, Teva, Theravance, UCB, and Zambon. P.L. reports advisory roles for Abide, Acorda Therapeutics, Adamas, Biogen, Cavion, Denali, Intec Pharma, Jazz Pharmaceuticals, Lundbeck, Neurocrine, Mitsubishi NeuroDerm, Prexton, Revance, Sage, and US WorldMeds; lecture fees from US WorldMeds, Acorda, American Academy of Neurology, and Kyowa Hakko Kirin; and research grant support from Abide, Acorda, Amneal, Lundbeck, The Michael J. Fox Foundation for Parkinson's Research, Mitsubishi, NeuroDerm, Parkinson Study Group, Pharma 2B, Revance, Hoffmann‐La Roche, Sunovion, Sun Pharma, and US WorldMeds. He is the editor‐in‐chief of . C.W.O. and K.K. report owning shares in Clintrex which provides services for multiple pharmaceutical and biotech companies. T.S. has served as a consultant for Acadia, Abbvie, Accorda, Adamas, Allergan, Amneal, Aptinyx, Denali, General Electric (GE), Kyowa, Neuroderm, Neurocrine, Sanofi, Sinopia, Sunovion, Roche, Takeda, Voyager, US World Meds, Parkinson's Foundation, and The Michael J. Fox Foundation for Parkinson's Research; has served as a speaker and received an honorarium from Acadia and Adamas; is on the scientific advisory board for Neuroderm and Sanofi; and has received research funding from the NINDS, Parkinson's Foundation, The Michael J. Fox Foundation, Biogen, Roche, Neuroderm, Sanofi, Sun Pharma, Abbvie, IMPAX, and Prevail. A.T. reports consulting fees from Newron, Zambon, and NeuroDerm. L.A., R.C., and T.Y. are employed by NeuroDerm. N.S. provides biostatistical services to NeuroDerm. S.O., S.F.O., and O.R. were employed by NeuroDerm at the time of the study. A.J.E. has received grant support from the NIH and The Michael J. Fox Foundation; personal compensation as a consultant/scientific advisory board member for Abbvie, Neurocrine, Amneal, Adamas, Acadia, Acorda, InTrance, Sunovion, Lundbeck, and US WorldMeds; publishing royalties from Lippincott Williams & Wilkins, Cambridge University Press, and Springer; and honoraria from US WorldMeds, Acadia, Sunovion, the American Academy of Neurology, and the Movement Disorders Society. Clinical Neuropharmacology Publisher Copyright: {\textcopyright} 2021 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.",
year = "2021",
month = nov,
doi = "10.1002/mds.28758",
language = "English (US)",
volume = "36",
pages = "2687--2692",
journal = "Movement Disorders",
issn = "0885-3185",
publisher = "John Wiley and Sons Inc.",
number = "11",
}