如何给帕金森病患者服用卡比多巴-左旋多巴缓释胶囊（IPX203, CREXONT®）

IF 1.8 Q3 CLINICAL NEUROLOGY

Clinical Parkinsonism Related Disorders Pub Date : 2025-01-01 DOI:10.1016/j.prdoa.2025.100357

Robert A. Hauser , Yasar Torres-Yaghi , Stanley Fisher , Ghazal Banisadr

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引用次数: 0

摘要

IPX203 （CREXONT®）是一种新型口服缓释（ER）卡比多巴-左旋多巴（CD-LD）制剂，旨在快速达到与速释（IR） CD-LD相似的LD血浆浓度，并比其他口服CD-LD产品维持更长时间的LD浓度。在关键的3期临床试验中，IPX203以更少的剂量提供了优于IR CD-LD的临床益处。由于IPX203的血浆浓度分布与IR LD不同，因此将IR LD治疗的患者转化为IPX203需要一种转化策略。在关键的3期试验中，IR CD-LD患者根据IR CD-LD稳定给药方案中最常见的单剂量转换为IPX203。大多数患者最初每天给药3次IPX203。然后根据临床反应进行进一步的滴定，患者每天给药2至4次。在589名先前接受IR CD-LD治疗的患者中，506名患者完成了IPX203的转换；个体剂量的mg转换比在剂量转换期开始时为2.8，滴定至临床反应后为2.9，大多数IPX203患者（84%）每天给药3次。目的为IPX203 （CREXONT®）临床用药提供指导。

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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 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.