1. Duration of "Good On" time per dose: Immediate-release carbidopa-levodopa vs. extended-release carbidopa-levodopa (IPX203, CREXONT®).
- Author
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Hauser RA, Fernandez HH, Jimenez-Shahed J, Allard S, Banisadr G, Fisher S, and D'Souza R
- Subjects
- Humans, Male, Female, Middle Aged, Aged, Double-Blind Method, Time Factors, Carbidopa administration & dosage, Levodopa administration & dosage, Levodopa pharmacology, Delayed-Action Preparations, Parkinson Disease drug therapy, Drug Combinations, Antiparkinson Agents administration & dosage
- Abstract
Background: For Parkinson's disease patients with motor fluctuations, the duration of benefit per levodopa dose is a key metric that reflects a patient's clinical response., Objective: Determine the difference in mean durations of "Good On" time per dose of subjects randomized to extended-release carbidopa-levodopa (ER CD-LD; IPX203; CREXONT®) vs. immediate-release (IR) CD-LD in the RISE-PD trial., Methods: "Good On" time per dose was assessed at the end of the IR CD-LD dose adjustment phase (Visit 2/Week 3) and compared to End of Study (Visit 7/EOS) between IPX203 and IR CD-LD groups. In addition, to understand if "Good On" time per dose for IR CD-LD before conversion to IPX203 could impact the magnitude of change in "Good On" time per dose of IPX203 vs. IR CD-LD after conversion, subjects were rank-ordered and divided into quartiles based on their initial "Good On" time per dose optimized IR CD-LD values. Changes in "Good On" time per dose between IPX203 and IR CD-LD groups were then compared for each quartile from Visit 2 to EOS., Results: IPX203 increased "Good On" time per dose compared to IR CD-LD by a mean of 1.6 h (p < 0.0001). The mean differences in "Good On" time per dose between IPX203 and IR CD-LD were 1.53h for quartile one, 1.39h for quartile two, 1.83h for quartile three, and 1.56h for quartile four (p < 0.0001 for all quartiles)., Conclusion: IPX203 significantly increased "Good On" time per dose regardless of the duration of "Good On" time per dose observed with IR CD-LD., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: R.A.H. has received speaking fees from Amneal Pharmaceuticals, Cerevel, Kyowa Kirin, Neurocrine Biosciences, and Supernus. R.A.H. has received consulting fees from Abbvie, Ameal, Avanex, Biogen, BlueRock, Cerevel, Forsee Pharmaceuticals, Inhibikase, Intrance (PSG), Jazz Pharmaceuticals, Kiefe RX, Kyowa Kirin, MDCE Suzhou, MedRythms, Merz, Mitsubishi Tanabe, Neurocrine, Neuroderm, Pharma Two B, Regenxbio, Revance, Serina Therapeutics, Stoparkinson, Supernus, Tolmar, Tremor Research Group, Tris Pharma, Truebinding, UCB, Vivifi, and Zambon. R.A.H. serves on a scientific advisory board for Stoparkinson and Inhibikase. R.A.H. holds stock in Revance Therapeutics and has stock options in Enterin, Inhibikase, and Axial Therapeutics. R.A.H. has received intellectual property interests from a PD Diary through his University. R.A.H. acknowledges a Center of Excellence grant from the Parkinson Foundation. R.A.H.’s University has received research support from Annovis Bio, Inc., Artizan Biosciences, Parkinson's & Movement Disorder Alliance, Inhibikase Therapeutics, AbbVie, Inc., Biogen MA, Bukwang Pharmaceutical Co., Ltd., Cavion, Inc., Cerevance, Inc., Cerevel Therapeutics, Cynapsus Therapeutics, Enterin, Inc., Genentech, Global Kinetics Corporation, Hoffman-La Roche Inc., Impax Laboratories, Integrative Research Laboratories Sweden, Lundbeck, Inc., Michael J. Fox Foundation for Parkinson's Research, National Parkinson's Foundation, Neuraly Inc., Neurocrine Biosciences, Neuroderm, Pharma Two B Ltd, Revance Therapeutics, Sage Therapeutics, Sanofi Pharmaceuticals, Scion NeuroStim, SunPharma and UCB BioPharma. H.H.F has received consulting fees from Abbvie, Amneal, Cerevel, and Neurocrine. H.H.F has received grants or contracts from Biogen, BlueRock, Michael J. Fox Foundation, Parkinson's Foundation, Parkinson Study Group and Roche. H.H.F. served on advisory board for Amneal and Cerevel. H.H.F receives royalties from Springer Publishing. H.H.F. serves as Editor in Chief of Parkinsonism and Related Disorders with Elsevier and Co-Chair of Executive Committee of Parkinson Study Group. J.J. has received consulting fees from Abbvie, BlueRock, Kyowa Kirin, Medtronic, Regenxbio, and Teva. J.J. has received research support from Annovis, BlueRock, ONO Pharmaceuticals, and Sage. J.J. served on advisory board for Photopharmics. J.J. served on the Data and Safety Monitory Board for BlueRock and Emalex Biosiences. S.A., G.B., S.F., and R.D. are employees of Amneal Pharmaceuticals, LLC., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)
- Published
- 2025
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