近日，美国食品和药品监管局FDA批准便秘新药Trulance（plecanatide），用于治疗成年患者慢性特发性便秘。
Trulance是每日一次的口服剂，用于上消化道，帮助肠液分泌，并促进规律的排便。
FDA的药品评价和研究中心中药品评价药品评价III室主任Julie Beitz，M.D.说：“没有一个药物对患慢性胃肠道疾病的所有患者起作用，” “随新治疗的可供利用，患者和他们的医生可对他们的情况选择最适宜治疗。”
批注日期：2017年1月19日：公司：Synergy Pharmaceuticals Inc
TRULANCE(plecanatide)片，为口服使用
美国初次批准：2017
作用机制
Plecanatide是结构上与人尿鸟苷蛋白[uroguanylin]相关，和相似于尿鸟苷蛋白，plecanatide 功能作为一个鸟苷酸环化酶-C(GC-C)激动剂。Plecanatide及其活性代谢物两者结合至GC-C和局部地作用于肠上皮的腔表面。GC-C的活化导致细胞内和细胞外两者环鸟苷酸(cGMP)浓度的增加。细胞内cGMP的升高刺激氯化物和碳酸氢盐得到分泌至小肠腔，主要地通过囊性纤维化跨膜传导调节剂[cystic fibrosis transmembrane conductance regulator(CFTR)]离子通道的活化，导致小肠液增加和加速通过。在动物模型中，plecanatide曽b欸显示增加液体分泌至胃肠(GI)道，加速小肠通过，和引起粪便粘稠度变化。
在内脏痛的动物模型中，plecanatide减低异常肌肉收缩，小肠疼痛的一种测量。尚未研究其机制。
适应证和用途
TRULANCE是一种鸟苷酸环化酶-C激动剂适用在成年中为慢性特发性便秘(CIC)的治疗。
剂量和给药方法
TRULANCE的成年推荐剂量是3mg口服使用每天1次。
给药指导：
●有或无食物服用。
● 对难以吞咽整片患者或用一鼻胃或胃饲管患者，见完整处方资料与对粉碎片和与苹果酱或水给予指导。
剂型和规格
片：3mg
禁忌证
● 患者低于6岁由于严重性脱水的风险。
● 有已知或怀疑机械性胃肠道阻塞患者。
警告和注意事项
腹泻：患者可能经受严重的腹泻。如发生严重的腹泻，暂停给药和再水化患者。
不良反应
最常见不良反应(≥2%)是腹泻。
供应/贮存和处置
TRULANCE片被包装在一个儿童安全包铝箔单位剂量吸塑30片包装或在一个白色，不透明，高密度聚乙烯圆瓶有一个螺旋-顶部聚丙烯防儿童-盖和热活化诱导密封。每瓶容器-系统还含干燥剂和聚酯线圈。
TRULANCE 3mg片是白色至米白色，平坦和圆形，在一侧凹陷有“SP” 和在另一侧对3mg “3” 和供应为：
NDC号           大小规格
70194-203-30    30片瓶
70194-003-30    在一个儿童安全包铝箔单位剂量吸入塑30片包装
贮存在室温，20至25°C(68至77°F)；外出允许至15至30°C(59至86°F) [见USP控制室温]。
保存TRULANCE在一个干燥部位。避潮保护。对瓶，保存TRULANCE在原始瓶内。不应将干燥剂从瓶中取出。不要分装或重新包装。

Relieve Your Constipation with this New FDA Approved Drug
Constipation gives you the toughest start of every day.
Now, FDA has approved Synergy Pharmaceuticals’ Trulance™ (plecanatide) to treat adults suffering from chronic idiopathic constipation (CIC). It is the first drug that is designed to replicate the role of uroguanylin.
Uroguanylin is a naturally occurring and endogenous human gastrointestinal (GI) peptide which is believed to stimulate the secretion of the fluid needed to regulate the bowel function and stool consistency.
More than 2,600 patients were treated with Trulance during clinical trials. Over 12 weeks, patients showed significantly efficient results in the complete spontaneous bowel movements and an improved stool frequency and consistency.
Constipation can have serious negative effect in your day to day life which involves unpleasant symptoms like discomfort while going for bathroom, pain due to hard, dry and difficult to pass stool, swollen belly after eating.
Drinking more water and increased intake of fiber in the diet are the most basic remedies to ease the constipation problem
CIC affects about 14 percent of the global population. Trulance is approved as a 3mg once daily tablet for the treatment of adult patients having CIC. It is almost structurally related to uroguanylin, therefore, will target GC-C receptors primarily present in the small intestine coinciding with areas of fluid secretion.
A herbal laxative Senna is commonly available over-the-counters to relieve constipation but it is not recommended for pregnant, breastfeeding women or those having have certain health conditions, like inflammatory bowel disease.The glycosides present in them stimulate your gut nerves and speed up bowel movements.
Trulance has also completed two late-stage clinical trials to treat irritable bowel syndrome with constipation (IBS-C). The company plans to file a New Drug Application Supplement with Clinical Data (sNDA) later this quarter. Around this time, Trulance will be available in the US for CIC patients.
 “TRULANCE presents an exciting new treatment option for patients with chronic constipation.
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