小体积结肠镜检查准备剂Prepopik通过审批

圣路易斯(MD Consult)——2012年7月17日，美国食品药品管理局(FDA)与辉凌制药公司宣布，口服液Prepopik(匹可硫酸钠、氧化镁和无水柠檬酸)已通过审批，该药适用于成人行结肠镜检查前的结肠清洁。Prepopik是一种小体积(总共10 盎司)、橙味的兴奋剂兼容积性泻药。

FDA批准该药是基于2项关键的3期非劣效研究，共涉及大约1,200例拟行结肠镜检的成人患者。这两项研究分别对Prepopik与2 L聚乙二醇电解质溶液(PEG+E)及25 mg比沙可啶片进行了比较，其结果均显示，Prepopik达到了主要终点(以Aronchick量表判定结肠清洁成功)，表明其不劣于对照。另外，统计学结果显示，Prepopik在清洁结肠方面优于对照。

Prepopik处置组的成人患者报告最多的不良反应有恶心、头痛及呕吐。

FDA批准了Prepopik 2项用药方案。单剂Prepopik包括2包粉剂，均在不同时间以冷水冲服，最好根据美国胃肠病学会推荐的分剂量法服用，即在进行结肠镜检查的前一晚及当天早晨服用。对于不宜采取分剂量法的患者，还可考虑结肠镜检查的时间安排、旅途的长短及其他个人具体情况，在进行结肠镜检查的前一天用药。

该结肠清洁方案中还包括患者必须在服用Prepopik时及之后增加液体摄入量，这种做法也有助于降低体液和电解质失衡风险。

Prepopik预计将在2012年10月上市。

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ST LOUIS (MD Consult) - On July 17, 2012, the US Food and Drug Administration (FDA) and Ferring Pharmaceuticals announced the approval of Prepopik (sodium picosulfate, magnesium oxide, and anhydrous citric acid) for oral solution, indicated for cleansing of the colon as a preparation for colonoscopy in adults. Prepopik is a low-volume (10 oz total), orange-flavored, dual-acting, stimulant and osmotic laxative.

The FDA approval was granted on the basis of data from 2 pivotal phase 3 noninferiority studies that included approximately 1200 adult patients scheduled to undergo a colonoscopy. In these studies, Prepopik was compared with a 2-liter solution of polyethylene glycol plus electrolytes (PEG+E) and 2 5-mg bisacodyl tablets. In both studies, Prepopik achieved the primary end point (successful colon cleansing as determined by the Aronchick Scale), demonstrating noninferiority to the comparator. Additionally, Prepopik demonstrated statistical superiority in cleansing of the colon versus the comparator.

The most common adverse effects reported in adult patients receiving Prepopik included nausea, headache, and vomiting.

Prepopik is approved with 2 dosing options. One dose of Prepopik consists of 2 packets of powder, each dissolved in cold water and taken at separate times. Preferably, Prepopik can be given according to the American College of Gastroenterology's recommended split-dose regimen in which the first dose is taken in the evening before and the second dose taken on the morning of the procedure. Day-before dosing is an alternative regimen for patients for whom split-dosing is inappropriate, accounting for colonoscopy scheduling, distance traveled, and other personal circumstances.

As part of this colon-cleansing regimen, patients receiving Prepopik must consume additional fluids during and after use. Additional fluid intake is also important to reduce the risk of fluid and electrolyte imbalance.

Prepopik is expected to be available in October 2012.