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

Period of Performance: 08/01/2017 - 07/31/2018

$987K

Phase 2 SBIR

Recipient Firm

Elysium Therapeutics, Inc.
DANVILLE, CA 94506
Principal Investigator

Abstract

Project Summary / Abstract Addiction is a disease. According to the National Institute on Drug Abuse, addiction can be hereditary, and can be triggered by environmental conditions and behavior. One key environmental factor involves the ready access to unused prescription opioids by potential abusers, especially teens. Elysium has discovered a novel molecular deactivation (XpiRx? or ?expiring pill?) technology that is designed to effectively curb the widespread stockpiling, diversion, abuse, and overdose of unused prescription opioids, even by the most common route of abuse, oral ingestion. Current opioid pills lose only <1% of their potency per year, resulting in a 70- year potency half- life. Using Elysium?s XpiRx technology, prescription opioids will provide effective analgesia to pain patients, then safely and irreversibly lose their potency after their prescribed- use period lapses, rendering them (i) unattractive to recreational and chronic abusers, and (ii) significantly less likely to elicit potentially lethal respiratory depression effects when overdosed. Broad used of Elysium?s XpiRx technology would substantially decrease the pool of opioid drugs currently available to abusers and addicts, and reduce the risk of overdose. Key stakeholders have expressed strong interest in technologies to curtail diversion of prescription opioids: · 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). Experts have indicated that they are not aware of any technologies in development or on the market that address prescription opioid diversion. Under our initial SBIR Fast- Track Grant (1R44DA037908), we achieved several key milestones: (i) identified lead and backup development candidates;? (ii) discovered two proprietary strategies to achieve targeted product profiles;? (iii) demonstrated proof of concept for two potential target product profiles with life- saving potential;? (iv) generated significant commercial interest;? and (v) obtained critical feedback from the FDA. We intend to build on the successful progress under our initial Fast Track Grant with this proposed SBIR Phase IIB Continuation Grant. The overall objective of this grant proposal is to qualify a lead XpiRx immediate- release product candidate for human clinical studies by completing requisite IND- enabling studies. These activities will have a meaningful impact on advancing our lead XpiRx product candidate toward FDA approval and a commercialization deal with a larger pharmaceutical company.