阿斯利康在美国推出便秘新药Movantik

2015年4月2日讯/生物谷BIOON/--英国制药巨头阿斯利康（AZN）近日与合作伙伴第一三共制药（DaiichiSankyo）联合在美国推出便秘新药Movantik（naloxegol），该药是一种外周作用μ-阿片受体拮抗剂（PAMORA），专门用于治疗患者在服用阿片类药物时所引发的便秘(OIC)，这是阿片类止痛药一种常见的副作用。
Movantik分别于2014年9月和12月获美欧2大市场批准，是市场中首个每日一次的口服外周作用μ-阿片受体拮抗剂（PAMORA）。naloxegol由Nektar利用其专有的口服小分子聚合物共轭技术开发，阿斯利康与Nektar在2009年签署15亿合作协议，将naloxegol收入囊中。阿斯利康对naloxegol充满了信心，坚信该药将为双方带来丰厚的回报。有分析师预计，阿片诱导性便秘（OIC）市场到2017年将达到19.8亿美元。尽管主要对手Salix公司类似产品Relistor于去年9月底获FDA批准用于OIC，但该药是一种皮下注射药物，naloxegol独特的口服优势使Relistor难以与之抗衡。
Movantik的获批是基于KODIAC临床项目的数据，该项目包括2个关键性III期研究（KODIAC-04和KODIAC-05)，这2项研究均证实25mg剂量Movantik能够显著提高缓解者比例，同时显著缩短首次自发排便（SBM）的平均时间。尽管这些研究中，Movantik治疗组出现了一些不良反应，包括腹痛、腹泻、恶心、头痛、胀气；但在推荐剂量下，Movantik对中枢神经系统的渗透可以忽略不计，限制了与阿片类药物潜在的相互干扰。
阿片诱导性便秘（OIC）：
阿片类药物（Opioids）通过结合存在于大脑及中枢神经系统（CNS）其他部位的μ-阿片受体发挥作用，但这类药物也能结合存在于胃肠道的μ-阿片受体，这反过来会导致阿片诱导性便秘（OIC），而这是阿片类药物已知的最主要的副作用，通常会持续于整个治疗过程。
英文原文：AstraZenecaplc(ADR)LaunchesItsConstipationTreatment,MOVANTIK,InUS
Movantikisthefirsteveronce-dailymedicineindicatedforOICpatientsandafterthedrug’sfinallaunch,AstraZenecaisboundtoenjoyasignificantadvantagewithitsfirstmover’spositioninthemarketforthesaidtreatment
AstraZenecaPlcADR(NYSE:AZN)hasjustannouncedthelaunchofitsopioid-inducedconstipation(OIC)treatment,brandnamedMovantik.Thedrug,alsoknownbyitschemicalnamenaloxegol,willbepromotedinajointeffortJapanesedrugmaker,DaiichiSankyo(OTCMKTS:DSNKY).
Movantik,firstreceivedgotthegoaheadfromtheUSFoodandDrugAdministration(FDA)inSeptemberlastyear.Itwasapprovedforuseasaperipherally-actingmu-opioidreceptorantagonist(PAMORA)fortreatingopioid-inducedconstipationinadultpatientsexperiencingchronic,non-cancerpain.ThismakesMovantiktheveryfirstonce-dailymedicineforOICpatients.WhenMovantikisactuallyavailable,theBritishdrugmaker’sfirstmoverpositioncouldgiveasignificantmarketadvantage.
Opioidsworkbycombiningtomu-receptorsfoundinsidethebrainandotherpartsofthecentralnervoussystem(CNS).Theyalsobindtothosemu-receptorspresentinthegastrointestinaltract.Inturn,thisleadstoOIC.OICisknowntobeoneofthemajorsideeffectsofdrugscontainingopioidsandusuallypersiststhroughoutthetreatmentcourse.
TheFDA’sdecisiontogivethegreenlighttoAstraZeneca’sMovantik,cameoutofpositiveresultsfromtheKODIACclinicalprogram.Thisprojectwascomposedoftwomainlatestagetrials,namedKODIAC‐04andKODIAC‐05,whichestablishedtheeffectivenessofnaloxegotreatingforOIC,ascomparedwiththosetestedwithaplacebo.Givenata25mgdoseoncedaily,Movantikdemonstratedasignificantresponserateinpatientswhounderwenta12weektreatment.AlthoughthereweresideeffectsinOICpatients,includingnausea,flatulence,vomiting,headache,diarrheaaswellasabdominalpain.
InapressstatementonhowMovantikworks,itssafetyandefficacyintreatingOIC,USMedicalLeadatAstraZeneca,CathyDattosaid,“Movantikprovidesanoraltreatmentoptionthat’sspecificallydesignedforpatientsstrugglingwithopioid-inducedconstipation.Whenadministeredatrecommendeddoselevels,Movantikdecreasestheconstipatingeffectofopioidsbyblockingopioidsfrombindingtomu-receptorsinthebowel.Andbecauseofitsdesign,atrecommendeddoses,thecentralnervoussystempenetrationofMovantikisexpectedtobenegligible,limitingthepotentialforinterferencewithopioidpainrelief.”
JapanesepharmaceuticalcompanyDaiichiSankyoInc.willco-commercializeMovantikinsideUS,inlinewiththeagreementreachedwiththeBritishdrugmakeronMarch19th2015.Daiichi’ssalesforcewillbejoiningAstraZenecatopromotethenewOICtreatmentbyMaythisyear.Underthedeal,AstraZenecawillcarryoutallthemanufacturingoperationswhilealsobeingresponsibleforbookingallproductsales.Daichiiontheotherhand,wouldbeentitledtoreceiveapreagreedsalescommissionfromtheBritishcompany.
VicePresidentofSpecialtyCareatAstraZeneca,DaveFredrickson,saidthedrug’slaunchwasinlinewiththecompanymission.Hesaid,“AtAstraZeneca,patientsareatthecoreofwhatwedoeveryday,andit’sthisfocusthatdrivesustobringfirst-in-classoralmedicineslikeMovantiktothemarket.”Heisoptimisticaboutthehighgrowthpotentialofthedrug,saying,“Weknowmanypatientstakingopioidsforchronicnon-cancerpainoftenexperienceOIC,andwebelieveMovantikisanimportanttreatmentoptionforthoseunabletoeffectivelymanagetheirsymptoms.”
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