MADDERS® - Analgesic Solutions

MADDERS, developed in response to the FDA-ACTTION initiative, is applicable to all CNS-acting drugs including such indications as pain, depression, anxiety, ... AboutUs AnalgesicFundamentals AnalgesicAdvantage News Careers QDSS MADDERS® Training AccuratePainReporting–APR PlaceboResponseReduction–PRR PainToolbox BedsideSensoryTestingKit FASTAssessment STEPP MasqueradingDisordersTool OpioidInducedHyperalgesia CentralEligibilityVerification ContactUs MADDERS® AnalgesicSolutionsdevelopedtheMisuse,Abuse,andDiversionDrugEventReportingSystem(MADDERS®)inresponsetoaninitiativebytheACTTIONFDApublic-privatepartnershiptoaddresstheneedforstandardizedapproachestoquantifyingpotentialabuseinclinicaltrials MADDERS®identifiespotentialabuseormisuseeventsthatwerenotalreadyclassifiedasanadverseeventofinterestordrugaccountabilitydiscrepancy LEARNMORE AdverseeventanddrugdiscrepancyfromclinicalsitesundergoesfinalanalysisbytheMADDERS®AdjudicationCommitteewhichprovidesfinalclassificationdeterminedbythesubjectmatterexperts LEARNMORE MADDERS®assistsinthegenerationofevidencetosupportapproval,labeling,andschedulingdecisionsfordrugswithCNSactivity LEARNMORE REQUESTADDITIONALINFORMATION AssessingAbusePotential:RegulatoryRequirements Asof2017,allinvestigationaldrugproductswithpossibleCentralNervousSystem(CNS)activityarerequiredbytheFDAtobecomprehensivelyassessedforabuseliability.MADDERSprovidesarobustassessmentofyourmedication’sabuseliabilitytosupportappropriateapproval,labelingandschedulingdecisions. MADDERS,developedinresponsetotheFDA-ACTTIONinitiative,isapplicabletoallCNS-actingdrugsincludingsuchindicationsaspain,depression,anxiety,ADHDandepilepsy. MADDERSutilizestrainedinvestigatorsandanAdjudicationCommitteeto: Activelyidentifypotentially-abuserelatedevents Completeevent-relatedquestionnaires Classifyeventsaccordingtoconsensusterminology MADDERS5-StepProcess EvidenceSupportingMADDERS ThedevelopmentandvalidationofMADDERSwaspresentedinarecentpaperpublishedbythe TheAmericanJournalofAddiction.MADDERShasbeensuccessfullyimplementedinover14clinicaltrialsinvariousindications,includingchronicpainandepilepsy. “WeareawareofnoassessmentotherthanMADDERSthatgathersasmuchinformationaboutinappropriatemedicationuseeventsinanattempttodiscerntheputativeintentunderlyingtheevent.Infact,thevalueofthesystemliesinitsfocusonsufficientlydocumentingtriggeringeventsthatoccurintrials,ratherthancharacteristicsoftheindividualsinthetrial.” -ALERTTWorkingGroupofACTTION MADDERSBrochure ©Copyright2017.AnalgesicSolutions.Allrightsreserved. Scrolltotop SUBSCRIBE tothe ANALGESICSOLUTIONS NEWSLETTER SignuptodaytoreceivetheAnalgesicAdvantagee-newsletter.Learnaboutindustrynews,clinicaltrialstudiesandadvances,newtechnicalpapersandmuchmore. X