——结肠 清洗粉剂Prepopik获美国FDA正式批准上市

2012年7月16日，美国食品与药物管理局（FDA）批准了Prepopik（有效成分：匹可硫酸钠、氧化镁和柠檬酸）用于辅助成人患者在行结肠镜检查的准备阶段净化结肠。

一剂用量Prepopik包含2包粉剂，患者在不同时间段用冷水冲服每包粉剂。服用时间为患者行结肠镜检查的前一天晚上和当天早上（分次剂量法），若不能按照上述服用方法服用，患者也可在行结肠镜检查的前一天下午和晚上服用（前一天服用法）。

作为结肠净化方案的一部分，服用Prepopik的患者还必须在服用期间和服用之后使用其他的液体，这种额外的液体能量摄入对于减少患者体液和电解质失衡风险也非常重要。已报告的服用Prepopik的成人患者的最常见不良反应包括恶心、呕吐和头痛。

伴随着Prepopik的获准，制造厂家还必须进行确定儿童使用该药的安全性和有效性研究。

Prepopik Approved for Colonoscopy Prep
July 17, 2012

PREPOPIK (sodium picosulfate,magnesium oxide,anhydrous citric acid) 10mg/3.5g/12g packets by Ferring
RELATED CONDITIONSConstipation and bowel cleansers  Ferring Pharmaceuticals announced that the FDA has approved Prepopik (sodium picosulfate, magnesium oxide, and anhydrous citric acid powder) for oral solution indicated for cleansing of the colon as a preparation for colonoscopy in adults. Prepopik, a stimulant and osmotic laxative, is the lowest volume (10oz) active ingredient colon preparation that has been FDA-approved.

The FDA approval is based on data from two Phase III non-inferiority studies in which Prepopik was compared to 2L PEG+E plus two Bisacodyl 5mg tablets. In both studies, Prepopik achieved the primary endpoint (successful colon cleansing based on the Aronchick Scale), demonstrating non-inferiority to the comparator [Study 1: 84.2% vs. 74.4%; Study 2: 83.0% vs. 79.7%].

Prepopik will be available as two powder packets, each containing 10mg sodium picosulfate, 3.5g magnesium oxide, and 12g anhydrous citric acid.