FRANKFURTGermandrugmakerBoehringerIngelheimhasstoppeddevelopingadrugdubbedthe"pinkViagra"afterfailingtoconvinceU.S.regulatorstheexperimentalpillcouldboostwomen'ssexdrive.
"Thedecisionwasnotmadelightly,consideringtheadvancedstageofdevelopment,"chiefexecutiveAndreasBarnersaidonFridayofthehoped-formoneyspinneraimedatpremenopausalwomenwithapersistentandunexplainedlackofsexdrive.
Boehringer'smovemarkedthefailureofthelatestattempttofindafemalecounterparttoPfizer'sViagra,theblockbusterbluepillformen.Drugmakershavetestedvariouswaystoboostfemalelibido,butwomen'ssexliveshaveproveddifficulttotargetwithmedication.
U.S.governmentadviserssaidinJunethatBoehringer'spinkpill,basedontheactiveingredientflibanserin,offeredlittlehelptowomenandhadunacceptablerisks;nearly15percentofwomenstoppedtakingapillbeforeastudyendedduetosideeffectsincludingdepression,faintingandfatigue.
ThatledtheU.S.FoodandDrugAdministrationtoaskunlistedBoehringerinAugustformoreinformationonflibanserin,whichwouldhavebeenmarketedasGirosa.
"Theresponseoftheauthoritiesandthecomplexityandextentoffurtherquestionsthatwouldneedtobeaddressedtopotentiallyobtainregistrationforflibanserinhaveimpactedthecompany'sdecisiontofocusonotherpipelineprojects,"Boehringersaid.
Drugmakershavebeensearchingforamedicinetoimprovewomen'ssexlivessinceViagra'sdebut12yearsago.Themarketfora"pinkViagra"couldstretchintothebillionsofdollars.
NOMEDICINEFORLIBIDO
Originallydevelopedasanantidepressant,flibanserinwasbelievedtoactonbrainchemicalsthatplayaroleinsexualresponse.But,intrials,womenontheonce-a-daypill,takenatbedtimereportedunwantedsideeffects.
AnFDAadvisorycommitteevoted11-0inJunethatthedrug'srisksandbenefitswereunacceptableand10-1thateffectivenessdatawaslacking.
Boehringer,a125-year-oldcompanycontrolledbygreat-grandchildrenofthecompany'sfounder,saiditwouldnowmerelycompletethetwomostadvanceddrugtrials.
MaleimpotencepillsincludingViagraworkbywideningbloodvesselstoincreasethebloodflowneededforanerection.PfizerdroppedtestsofViagrainfemalesin2004afterstudiesfailedtoshowithelpedwomen.
TheflibanserinsetbackwasincontrasttoBoehringer'ssuccessinpioneeringanewbloodthinningpillforamarketthatrivalBayersaidcouldbeworth$15billion.
AU.S.advisorypanellastmonthrecommendclearanceofBoehringer'sPradaxapillforpreventingstrokesinpatientswithatypeofirregularheartbeat.
Thursday, March 17, 2011
Boehringer Pulls the Plug on 'Pink Viagra'
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