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

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44DA037908-04
Agency Tracking Number: R44DA037908
Amount: $2,962,537.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIDA
Solicitation Number: PA16-302
Timeline
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-08-01
Award End Date (Contract End Date): 2020-07-31
Small Business Information
111 DEERWOOD RD STE 385
San Ramon, CA 94583-1777
United States
DUNS: 078889753
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 THOMAS JENKINS
 (650) 839-3153
 tjenkins@elysiumrx.com
Business Contact
 ALEX STURMER
Phone: (650) 464-6175
Email: gsturmer@elysiumrx.com
Research Institution
N/A
Abstract

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

* Information listed above is at the time of submission. *

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