How to dose extended-release carbidopa-levodopa capsules (IPX203, CREXONT®) in patients with Parkinson’s disease

IPX203 (CREXONT®) is a novel, oral, extended-release (ER) carbidopa-levodopa (CD-LD) formulation, designed to rapidly achieve LD plasma concentrations similar to immediate-release (IR) CD-LD and to maintain LD concentrations for a longer duration than other oral CD-LD products. In the pivotal phase...

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Main Authors: Robert A. Hauser, Yasar Torres-Yaghi, Stanley Fisher, Ghazal Banisadr
Format: Article
Language:English
Published: Elsevier 2025-01-01
Series:Clinical Parkinsonism & Related Disorders
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Online Access:http://www.sciencedirect.com/science/article/pii/S2590112525000611
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author Robert A. Hauser
Yasar Torres-Yaghi
Stanley Fisher
Ghazal Banisadr
author_facet Robert A. Hauser
Yasar Torres-Yaghi
Stanley Fisher
Ghazal Banisadr
author_sort Robert A. Hauser
collection DOAJ
description IPX203 (CREXONT®) is a novel, oral, extended-release (ER) carbidopa-levodopa (CD-LD) formulation, designed to rapidly achieve LD plasma concentrations similar to immediate-release (IR) CD-LD and to maintain LD concentrations for a longer duration than other oral CD-LD products. In the pivotal phase 3 clinical trial, IPX203 provided superior clinical benefit with fewer doses than IR CD-LD. Since the plasma concentration profile of IPX203 is different from that of IR LD, converting patients treated with IR LD to IPX203 requires a conversion strategy. In the pivotal phase 3 trial, patients on IR CD-LD were converted to IPX203 based on the most frequent single dose of the patient’s stable dosing regimen of IR CD-LD. IPX203 was initially administered 3 times per day for most patients. Further titration was then undertaken based on clinical response, and patients were dosed 2 to 4 times per day. Of 589 patients previously treated with IR CD-LD, 506 patients completed the conversion to IPX203; the mg conversion ratio for individual doses was 2.8 at the beginning of the dose-conversion period and 2.9 after titration to clinical response, with the majority of IPX203 patients (84%) dosed 3 times per day. Objective: To provide guidance on dosing of IPX203 (CREXONT®) in clinical practice.
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series Clinical Parkinsonism & Related Disorders
spelling doaj-art-7f20102c186d4176b6e072b52f7775532025-08-20T04:00:43ZengElsevierClinical Parkinsonism & Related Disorders2590-11252025-01-011310035710.1016/j.prdoa.2025.100357How to dose extended-release carbidopa-levodopa capsules (IPX203, CREXONT®) in patients with Parkinson’s diseaseRobert A. Hauser0Yasar Torres-Yaghi1Stanley Fisher2Ghazal Banisadr3University of South Florida, Tampa, FL, United States; Corresponding author at: USF Parkinson’s Disease and Movement Disorders Center, Parkinson Foundation Center of Excellence, Tampa 33613, USA.MedStar Georgetown University Hospital, Washington, DC, United StatesAmneal Pharmaceuticals, LLC, 400 Crossing Boulevard, Bridgewater, NJ, United StatesAmneal Pharmaceuticals, LLC, 400 Crossing Boulevard, Bridgewater, NJ, United StatesIPX203 (CREXONT®) is a novel, oral, extended-release (ER) carbidopa-levodopa (CD-LD) formulation, designed to rapidly achieve LD plasma concentrations similar to immediate-release (IR) CD-LD and to maintain LD concentrations for a longer duration than other oral CD-LD products. In the pivotal phase 3 clinical trial, IPX203 provided superior clinical benefit with fewer doses than IR CD-LD. Since the plasma concentration profile of IPX203 is different from that of IR LD, converting patients treated with IR LD to IPX203 requires a conversion strategy. In the pivotal phase 3 trial, patients on IR CD-LD were converted to IPX203 based on the most frequent single dose of the patient’s stable dosing regimen of IR CD-LD. IPX203 was initially administered 3 times per day for most patients. Further titration was then undertaken based on clinical response, and patients were dosed 2 to 4 times per day. Of 589 patients previously treated with IR CD-LD, 506 patients completed the conversion to IPX203; the mg conversion ratio for individual doses was 2.8 at the beginning of the dose-conversion period and 2.9 after titration to clinical response, with the majority of IPX203 patients (84%) dosed 3 times per day. Objective: To provide guidance on dosing of IPX203 (CREXONT®) in clinical practice.http://www.sciencedirect.com/science/article/pii/S2590112525000611CREXONTIPX203LevodopaExtended-ReleaseParkinson’s DiseaseTreatment
spellingShingle Robert A. Hauser
Yasar Torres-Yaghi
Stanley Fisher
Ghazal Banisadr
How to dose extended-release carbidopa-levodopa capsules (IPX203, CREXONT®) in patients with Parkinson’s disease
Clinical Parkinsonism & Related Disorders
CREXONT
IPX203
Levodopa
Extended-Release
Parkinson’s Disease
Treatment
title How to dose extended-release carbidopa-levodopa capsules (IPX203, CREXONT®) in patients with Parkinson’s disease
title_full How to dose extended-release carbidopa-levodopa capsules (IPX203, CREXONT®) in patients with Parkinson’s disease
title_fullStr How to dose extended-release carbidopa-levodopa capsules (IPX203, CREXONT®) in patients with Parkinson’s disease
title_full_unstemmed How to dose extended-release carbidopa-levodopa capsules (IPX203, CREXONT®) in patients with Parkinson’s disease
title_short How to dose extended-release carbidopa-levodopa capsules (IPX203, CREXONT®) in patients with Parkinson’s disease
title_sort how to dose extended release carbidopa levodopa capsules ipx203 crexont r in patients with parkinson s disease
topic CREXONT
IPX203
Levodopa
Extended-Release
Parkinson’s Disease
Treatment
url http://www.sciencedirect.com/science/article/pii/S2590112525000611
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