Unprecedented Diversion-/Abuse-Resistance: Molecular Deactivation of Opioid Drugs

DESCRIPTION Elysium has discovered a novel molecular deactivation XpiRxandquot or andquot expiring pillandquot technology that is designed to effectively curb the widespread abuse and diversion of unused prescription opioid drugs Using Elysiumandapos s technology opioid drug products will safely and irreversibly lose their potency over a specified time window beyond the prescribed use period rendering them devoid of opioid agonist effects and therefore completely abuse resistant Our XpiRx technology enables i effective pain relief during the prescribed use period ii abuse resistance via non oral routes iii oral abuse deterrence beyond the prescribed use period and iv oral overdose protection beyond the programmed expiration date According to President Obama andquot Prescription drug abuse is Americaandapos s fastest growing drug problem and one largely fed by an unlikely source Americansandapos medicine cabinets andquot Over of abusers obtain unused prescription opioids from their friends and family Current opioid pills lose only of their potency per year resulting in a year potency half life Elysiumandapos s XpiRx technology dramatically shortens the opioid drugandapos s potency half life which would substantially decrease the pool of drugs andquot diversion poolandquot that attract abusers We are applying for Fast Track because NIDA program officials assured us that our proposed project is an excellent Fast Track candidate based on Compelling in vitro data from studies led by our Principal Investigator coupled with published Phase human data demonstrate the feasibility of achieving unprecedented abuse and diversion resistance with XpiRx technology The lack of technologies in development or on the market that address diversion the primary source for abused prescription opioid drugs and Key stakeholder interest The Office for National Drug Control Policy ONDCP and The National Institute on Drug Abuse NIDA have identified diversion as a high priority issue because it fuels the prescription drug abuse epidemic Pharmaceutical company leaders believe that XpiRx could become a standard safety requirement for opioid drugs like airbags for automobiles PUBLIC HEALTH RELEVANCE The entwined epidemics of prescription opioid abuse and undertreated pain have given rise to the need for pain therapies that are less likely to be abused The Office for National Drug Control Policy ONDCP and The National Institute on Drug Abuse NIDA identified diversion as a high priority issue because it fuels the prescription drug abuse epidemic and there are no technologies in development or on the market that address this issue Elysium has discovered a novel molecular deactivation technology XpiRx or andquot expiring pillandquot that is designed to effectively curb the widespread diversion of unused prescription opioid drugs Using Elysiumandapos s technology opioid drug products will safely and irreversibly lose their potency over a specified time window beyond the prescribed use period rendering them devoid of opioid agonist effects and therefore completely abuse resistant