阿特维斯在美国推出新型避孕装置Liletta，避孕时间长达3年

2015年4月16日讯/生物谷BIOON/--仿制药巨头阿特维斯（Actavis）与非营利女性保健医药公司Medicines360联合宣布，在美国推出Liletta（左炔诺孕酮宫内缓释系统，52mg），这是一款宫内释药避孕装置，用于防止女性受孕，维持时间可长达3年。Liletta由医务人员放置在子宫内，通过连续释放孕激素左炔诺孕酮达到避孕目的。
Liletta是一款新的安全有效的宫内避孕给药装置（IUD），于2015年2月获得FDA批准。Liletta的获批，是基于在美国开展的迄今最大的激素IUD试验ACCESSIUS的数据。该研究调查了Liletta（52mg）的避孕效果及安全性，有1751例女性使用Liletta，数据显示，Liletta持续3年避孕有效率高达99.45%，且使用后女性BMI指数（体重指数）无明显改变。目前，该项研究仍在继续，以评估Liletta使用长达4、5、7年的安全性。
Liletta是一个小型柔性的塑料材质的T形系统，尺寸为32mm×32mm，通过缓慢释放左炔诺孕酮（LNG）发挥避孕作用，LNG初始的释放速率为18.6微克/天，在3年内的平均释放速率为15.6微克/天。
Liletta是一种长效“可逆”的新型激素IUD，适用于许多女性，不论年龄、BMI指数或是否有过生育史。女性可根据自己的需求，随时终止避孕；如需继续避孕，可更换新的Liletta。
英文原文：ActavisandMedicines360AnnounceU.S.AvailabilityofLILETTA™(levonorgestrel-releasingintrauterinesystem)52mgtoPreventPregnancyforuptoThreeYears
-LILETTA™NowAvailableinDoctorsOfficesandThroughPublicHealthClinics-
DUBLINandSANFRANCISCO,April13,2015/PRNewswire/--Actavisplc(ACT),aleadingglobalpharmaceuticalcompanyandleaderinwomenshealthcare,andMedicines360,anonprofitwomenshealthpharmaceuticalcompany,announcedtodaythatLILETTA™(levonorgestrel-releasingintrauterinesystem)52mgisnowavailableintheU.S.forusebywomentopreventpregnancyforuptothreeyears.
LILETTAwasapprovedbytheU.S.FoodandDrugAdministration(FDA)onFebruary26,2015,basedonthelargesthormonalIUDtrialconductedintheU.S.,ACCESSIUS(AComprehensiveContraceptiveEfficacy&SafetyStudyofanIUS).LILETTAisplacedintheuterusbyahealthcareprofessionalandworksbycontinuouslyreleasinglevonorgestrel,aprogestin,topreventpregnancy.
"TheavailabilityofLILETTAmarksanothersignificantachievementinwomenshealth,"saidCarolynWesthoff,MD,M.Sc,Professor,DivisionDirector,FamilyPlanningandPreventiveServices,ColumbiaUniversityMedicalCenter."ItscriticalthatwomenhavechoiceswhenitcomestotheirpreferredcontraceptionandIampleasedthatIcanoffermyappropriatepatientsthisnewsafeandeffectiveoption."
WiththeavailabilityofLILETTA,IUD-appropriatewomen,regardlessoffinancialstatusandinsurancecoverage,cannowaccessthisnewsafeandeffectiveIUDthroughActavisandMedicines360spartnership.LILETTAisnowcommerciallyavailableindoctorsofficesintheU.S.andthroughthisgroundbreakingpartnership,atalowerpriceforpublichealthclinicsenrolledinthe340BDrugPricingProgram.
"ThecommercialavailabilityofLILETTArepresentsaremarkablenextstepforwomenshealthintheU.S.,providingIUD-appropriatewomen,regardlessofincomeandinsurancecoverage,withasafeandeffectivecontraceptiveoption,"saidPamelaWeir,ChiefOperatingOfficer,Medicines360."Throughthistrulyinnovativepartnership,womenwillnowhaveanaccessible,affordableoptionforeffective,long-termcontraception."
"Actavisiscommittedtothecontinueddevelopmentandcommercializationofsafeandeffectivecontraceptivestoaddressunmetneedsinwomenshealth,"saidBillMeury,President,ActavisBrandedPharma."LILETTAisaprogestin-onlyintrauterinedevicewith>99%efficacydemonstratedover3years.OurgroundbreakingpartnershipwithMedicines360willprovideincreasedaccesstothisnovelIUDtowomenacrosstheprivateandpublichealthcaresystemsintheU.S."
AboutLILETTA™LILETTAisasmall,flexibleplasticT-shapedsystemwhichis32mmx32mminsize.Itworkstopreventpregnancybyslowlyreleasinglevonorgestrel(LNG),aprogestin,ataninitialreleaserateof18.6mcg/daywithanaverageinvivoreleaserateofLNGofapproximately15.6mcg/dayoveraperiodofthreeyears.Generally,LILETTAcanbeinsertedatanytimeiftheproviderisreasonablycertainthatthewomanisnotpregnant.WhileLILETTAisintendedforuseuptothreeyears,itcanberemovedbyahealthcareprofessionalatanytime.LILETTAcanbereplacedatthetimeofremovalwithanewLILETTA,ifcontinuedcontraceptiveprotectionisdesired.
AbouttheClinicalTrialforLILETTATheapprovalofLILETTAissupportedbythelargesthormonalIUDtrial(ACCESSIUS)conductedintheU.S.designedtoreflecttheU.S.population.Thismulticenteropen-labelclinicaltrialincluded1,751womenaged16-45whoreceivedLILETTA.Inwomen16to35,LILETTAwasfoundtobe99.45%effectiveinpreventingpregnancyinwomenregardlessofrace,parity(previousbirths),orbodymassindex(BMI).ThetrialisongoingtoevaluatetheuseofLILETTAforuptofour,fiveandsevenyears.
LILETTAwasstudiedinwomenaged16-45,withaBMIrangeof15.8kg/m2-61.6kg/m2(26.9kg/m2meanBMI)acrosswomenofvariousracesandethnicities.MostwomenwereCaucasian(78.4percent)orBlack/AfricanAmerican(13.3percent);14.7percentofwomenwereofHispanicethnicity.Nearly58percentoftrialparticipantswerenulliparous(hadnotpreviouslygivenbirth),thelargestpercentageofnulliparousIUDpatientseverstudied.
Inananalysisofwomenwhodiscontinuedthestudyearly,97percentreturnedtomenseswithinthreemonthsafterLILETTAwasremoved.Furthermore,inagroupofwomen(n=68)tryingtoconceive,87percentbecamepregnantwithinoneyearofremoval.Additionally,somewomenwereabletoconceiveassoonastwoweeksafterremoval(12days).Approximately19percentofwomentreatedwithLILETTAexperiencedamenorrhea(absenceofmenstruation)withinoneyearoftreatmentandmorethanone-thirdexperiencedamenorrheabythethirdyearoftreatment.
TheincidenceofectopicpregnancyintheclinicaltrialwithLILETTA,whichexcludedwomenwithahistoryofectopicpregnancywhodidnothaveasubsequentintrauterinepregnancy,wasapproximately0.12percentper100woman-years.
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