阿斯利康在美国推出便秘新药Movantik |
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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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