Attack Major Source of Abused Opioids: Molecularly Deactivate Unused Rx Opioids

Project SummaryAbstractAddiction is a diseaseAccording to the National Institute on Drug Abuseaddiction can be hereditaryand canbetriggeredbyenvironmentalconditionsandbehaviorOnekeyenvironmentalfactorinvolvesthereadyaccess to unused prescription opioids by potential abusersespecially teensElysium has discovered a novel molecular deactivationXpiRxorexpiring pilltechnology that is designedto effectively curb the widespread stockpilingdiversionabuseand overdose of unused prescription opioidsevenbythemostcommonrouteofabuseoralingestionCurrentopioidpillsloseonlyandltoftheirpotencyperyearresultinginayearpotencyhalflifeUsingElysium sXpiRxtechnologyprescriptionopioidswillprovideeffectiveanalgesiatopainpatientsthensafelyandirreversiblylosetheirpotencyaftertheirprescribeduseperiodlapsesrenderingthemiunattractivetorecreationalandchronicabusersandiisignificantly less likely to elicit potentially lethal respiratory depression effects when overdosedBroad used ofElysium sXpiRxtechnologywouldsubstantiallydecreasethepoolofopioiddrugscurrentlyavailabletoabusers and addictsand reduce the risk of overdoseKey stakeholders have expressed strong interest in technologies to curtail diversion of prescription opioidsThe Office for National Drug Control PolicyONDCPand The National Institute on Drug AbuseNIDAhave identified diversion as a high priority issue because it fuels the prescription drug abuse epidemicPharmaceuticalcompanyleadersbelievethatXpiRxcouldbecomeastandardsafetyrequirementforopioid drugslike airbags for automobilesExpertshaveindicatedthattheyarenotawareofanytechnologiesindevelopmentoronthemarketthataddress prescription opioid diversionUnderourinitialSBIRFastTrackGrantRDAweachievedseveralkeymilestonesiidentifiedleadandbackupdevelopmentcandidatesiidiscoveredtwoproprietarystrategiestoachievetargetedproductprofilesiiidemonstratedproofofconceptfortwopotentialtargetproductprofileswithlifesavingpotentialivgeneratedsignificantcommercialinterestandvobtainedcriticalfeedbackfromtheFDAWeintend to build on the successful progress under our initial Fast Track Grant with this proposed SBIR Phase IIBContinuationGrantTheoverallobjectiveofthisgrantproposalistoqualifyaleadXpiRximmediatereleaseproduct candidate for human clinical studies by completing requisite INDenabling studiesThese activities willhaveameaningfulimpactonadvancingourleadXpiRxproductcandidatetowardFDAapprovalandacommercialization deal with a larger pharmaceutical companyProject NarrativeThesignificanceoftheproposedresearchplanisbasedonthecontentionthattheinitialstepalongthepathway from initial experimentation with opioids to opioid addictionoften involves exposure and ready accesstoprescriptionopioidsTheestablishedmedicalparadigmsinvolvingitheincreasinguseofopioidsforthetreatmentofpainiitheoftenexcessivenumberofpillsprescribedtopatientsandiiithefactthatmanypatientsretainasignificantnumberoftheirunusedopioidsallcontributeinasignificantwaytothecurrentopioidabuseandaddictionepidemicsElysiumhasdiscoveredanovelmoleculardeactivationtechnologyXpiRxorexpiring pillthat safely and irreversibly forces opioids to lose their potency after the prescribeduseperiodinordertoeffectivelycurbthewidespreadstockpilingdiversionabuseandoverdoseofunusedprescription opioidseven by the most common route of abuseoral ingestion